|
C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; UNKNOWN SILICONE FOLEY CATHETER
|
Back to Search Results |
|
| Catalog Number UNKNOWN |
| Device Problem
Inaccurate Flow Rate (1249)
|
| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 07/22/2020 |
|
Event Type
malfunction
|
|
Manufacturer Narrative
|
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
| |
|
Event Description
|
|
It was reported that the first foley catheter was inserted in the patient after a surgical procedure on (b)(6) 2020.The catheter was injected with 300cc of saline and a voiding trial was attempted, but the patient could not urinate.The second catheter was inserted and injected with 300cc of saline again and a voiding trial was attempted, which was successful.The second catheter was removed, and the customer discharged from the hospital.One of the two catheters was not intact when it was removed from the patient.A piece of one of the catheters broke off and remained inside the patient¿s bladder for many months, until it was removed in (b)(6) 2020.The presence of the broken off catheter piece caused injury to the patient.The patient was scheduled for a postoperative visit on (b)(6) 2020.The patient having sharp abdominal pain and at some point, physicians believed that patient had a urinary tract infection and was prescribed antibiotics.The patient was restricted to their bed much of the time because movement would send sharp shooting pains through the abdomen and bladder.On (b)(6) 2020, patient saw a urologist due to continuing pain.On (b)(6) 2020, the physician scheduled a cystoscopy.During cystoscopy, bladder stones were found which would have to be surgically removed.Surgery was scheduled for (b)(6) 2020.During surgery, the physician removed not only bladder stones but also a foreign body consisting of a tubular shaped tan piece of plastic.The patient was informed and believed that this foreign body was a piece of one of the bardex foley catheter.The patient has no history of having a catheter prior to the first catheter.The customer was informed that the piece of catheter acted as a catalyst or incubation site for the development of the bladder stones.The customer's pain through the months of august through december 2020, which was initially attributed to a urinary tract infection, was in fact the result of the developing bladder stones.
|
| |
|
Event Description
|
|
It was reported that the first foley catheter was inserted in the patient after a surgical procedure on (b)(6) 2020.The catheter was injected with 300cc of saline and a voiding trial was attempted, but the patient could not urinate.The second catheter was inserted and injected with 300cc of saline again and a voiding trial was attempted, which was successful.The second catheter was removed, and the customer discharged from the hospital.One of the two catheters was not intact when it was removed from the patient.A piece of one of the catheters broke off and remained inside the patient¿s bladder for many months, until it was removed in (b)(6) 2020.The presence of the broken off catheter piece caused injury to the patient.The patient was scheduled for a postoperative visit on (b)(6) 2020.The patient having sharp abdominal pain and at some point, physicians believed that patient had a urinary tract infection and was prescribed antibiotics.The patient was restricted to their bed much of the time because movement would send sharp shooting pains through the abdomen and bladder.On (b)(6) 2020, patient saw a urologist due to continuing pain.On (b)(6) 2020, the physician scheduled a cystoscopy.During cystoscopy, bladder stones were found which would have to be surgically removed.Surgery was scheduled for (b)(6) 2020.During surgery, the physician removed not only bladder stones but also a foreign body consisting of a tubular shaped tan piece of plastic.The patient was informed and believed that this foreign body was a piece of one of the bardex foley catheter.The patient has no history of having a catheter prior to the first catheter.The customer was informed that the piece of catheter acted as a catalyst or incubation site for the development of the bladder stones.The customer's pain through the months of (b)(6) through (b)(6) 2020, which was initially attributed to a urinary tract infection, was in fact the result of the developing bladder stones.
|
| |
|
Manufacturer Narrative
|
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿lumen wall thickness undersized ¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the silicone catheter ifus are found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
| |
|
Manufacturer Narrative
|
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿lumen wall thickness undersized ¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
|
| |
|
Event Description
|
|
It was reported that the first foley catheter was inserted in the patient after a surgical procedure on 22jul2020.The catheter was injected with 300cc of saline and a voiding trial was attempted, but the patient could not urinate.The second catheter was inserted and injected with 300cc of saline again and a voiding trial was attempted, which was successful.The second catheter was removed, and the customer discharged from the hospital.One of the two catheters was not intact when it was removed from the patient.A piece of one of the catheters broke off and remained inside the patient¿s bladder for many months, until it was removed in december 2020.The presence of the broken off catheter piece caused injury to the patient.The patient was scheduled for a postoperative visit on august 7, 2020.The patient having sharp abdominal pain and at some point, physicians believed that patient had a urinary tract infection and was prescribed antibiotics.The patient was restricted to their bed much of the time because movement would send sharp shooting pains through the abdomen and bladder.On 23oct2020, patient saw a urologist due to continuing pain.On 25oct2020, the physician scheduled a cystoscopy.During cystoscopy, bladder stones were found which would have to be surgically removed.Surgery was scheduled for december 22, 2020.During surgery, the physician removed not only bladder stones but also a foreign body consisting of a tubular shaped tan piece of plastic.The patient was informed and believed that this foreign body was a piece of one of the bardex foley catheter.The patient has no history of having a catheter prior to the first catheter.The customer was informed that the piece of catheter acted as a catalyst or incubation site for the development of the bladder stones.The customer's pain through the months of august through december 2020, which was initially attributed to a urinary tract infection, was in fact the result of the developing bladder stones.Per additional information received via medical records on 22sep2022, the patient has experienced urinary retention, grade 2 cystocele, pain, chest pain, urgency, frequency, burning, acute cystitis, dysuria, hematuria, urinary incontinence, acute blood loss anemia, dizziness, urolithiasis, hydronephrosis and required additional surgical and non-surgical interventions.
|
| |
|
Event Description
|
|
It was reported that the first foley catheter was inserted in the patient after a surgical procedure on 22jul2020.The catheter was injected with 300cc of saline and a voiding trial was attempted, but the patient could not urinate.The second catheter was inserted and injected with 300cc of saline again and a voiding trial was attempted, which was successful.The second catheter was removed, and the customer discharged from the hospital.One of the two catheters was not intact when it was removed from the patient.A piece of one of the catheters broke off and remained inside the patient¿s bladder for many months, until it was removed in (b)(6) 2020.The presence of the broken off catheter piece caused injury to the patient.The patient was scheduled for a postoperative visit on (b)(6) 2020.The patient having sharp abdominal pain and at some point, physicians believed that patient had a urinary tract infection and was prescribed antibiotics.The patient was restricted to their bed much of the time because movement would send sharp shooting pains through the abdomen and bladder.On (b)(6)2020, patient saw a urologist due to continuing pain.On (b)(6)2020, the physician scheduled a cystoscopy.During cystoscopy, bladder stones were found which would have to be surgically removed.Surgery was scheduled for (b)(6) 2020.During surgery, the physician removed not only bladder stones but also a foreign body consisting of a tubular shaped tan piece of plastic.The patient was informed and believed that this foreign body was a piece of one of the bardex foley catheter.The patient has no history of having a catheter prior to the first catheter.The customer was informed that the piece of catheter acted as a catalyst or incubation site for the development of the bladder stones.The customer's pain through the months of august through december 2020, which was initially attributed to a urinary tract infection, was in fact the result of the developing bladder stones.Per additional information received via medical records on (b)(6)2022, the patient has experienced urinary retention, grade 2 cystocele, pain, chest pain, urgency, frequency, burning, acute cystitis, dysuria, hematuria, urinary incontinence, acute blood loss anemia, dizziness, urolithiasis, hydronephrosis and required additional surgical and non-surgical interventions.Per additional information received via medical records on (b)(6)2023, it was reported that on (b)(6) 2020, the patient underwent a surgical procedure at the end of the procedure, the patient placed with a bardex foley catheter, size 16 french (first catheter) at 1:25 p.M.The catheter was used to inject 300cc of saline into plaintiff's bladder.Then the catheter was removed at 7:25 p.M.To perform a voiding trial, but as a result of it the patient could not urinate.Therefore, at 10.00 p.M.Again a second catheter (bardex foley catheter size 16 french) was inserted, that second catheter remained in place until 8:00 a.M.On (b)(6)2020.It was stated that 300cc of saline was injected through the second catheter into plaintiff's bladder and then the second catheter was removed at 8:05 a.M.For another voiding trial, which was successful, and they noted that the second catheter intact when removed.On (b)(6)2020, during the post-operative visit.The patient had sharp abdominal pain.The physician believed that they had a urinary tract infections and prescribed antibiotics.On (b)(6)2020, the patient underwent a cystoscopy, as a result it was found what appeared to be bladder stones.To remove the bladder stones on (b)(6)2020, the patient underwent a surgery but what was removed were not only bladder stones but also a foreign body consisting of a tubular shaped tan piece of plastic measuring 1.5 x 0.5 x 0.1 cm.They believe that this foreign body was a piece of one of the bardex foley catheter.It was also stated that the patient has no history of having a catheter prior to the first catheter.Also, they allege that the piece of the catheter attributed to a urinary tract infection and development of bladder stones.According to this, a piece of one of the catheters broke off and remained inside the patient¿s bladder for many months until it was removed in (b)(6)2020.
|
| |
|
Manufacturer Narrative
|
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿lumen wall thickness undersized ¿.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.The device was not returned.
|
| |
|
Manufacturer Narrative
|
|
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿lumen wall thickness undersized ¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record review could not be performed without a lot number.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.
|
| |
|
Event Description
|
|
It was reported that the first foley catheter was inserted in the patient after a surgical procedure on (b)(6) 2020.The catheter was injected with 300cc of saline and a voiding trial was attempted, but the patient could not urinate.The second catheter was inserted and injected with 300cc of saline again and a voiding trial was attempted, which was successful.The second catheter was removed, and the customer discharged from the hospital.One of the two catheters was not intact when it was removed from the patient.A piece of one of the catheters broke off and remained inside the patient¿s bladder for many months, until it was removed in december 2020.The presence of the broken off catheter piece caused injury to the patient.The patient was scheduled for a postoperative visit on (b)(6) 2020.The patient having sharp abdominal pain and at some point, physicians believed that patient had a urinary tract infection and was prescribed antibiotics.The patient was restricted to their bed much of the time because movement would send sharp shooting pains through the abdomen and bladder.On (b)(6) 2020, patient saw a urologist due to continuing pain.On (b)(6) 2020, the physician scheduled a cystoscopy.During cystoscopy, bladder stones were found which would have to be surgically removed.Surgery was scheduled for (b)(6) 2020.During surgery, the physician removed not only bladder stones but also a foreign body consisting of a tubular shaped tan piece of plastic.The patient was informed and believed that this foreign body was a piece of one of the bardex foley catheter.The patient has no history of having a catheter prior to the first catheter.The customer was informed that the piece of catheter acted as a catalyst or incubation site for the development of the bladder stones.The customer's pain through the months of august through december 2020, which was initially attributed to a urinary tract infection, was in fact the result of the developing bladder stones.Per additional information received via medical records on (b)(6) 2022, the patient has experienced urinary retention, grade 2 cystocele, pain, chest pain, urgency, frequency, burning, acute cystitis, dysuria, hematuria, urinary incontinence, acute blood loss anemia, dizziness, urolithiasis, hydronephrosis and required additional surgical and non-surgical interventions.Per additional information received via medical records on 10jan2023, it was reported that on 22jul 2020, the patient underwent a surgical procedure at the end of the procedure, the patient placed with a bardex foley catheter, size 16 french (first catheter) at 1:25 p.M.The catheter was used to inject 300cc of saline into plaintiff's bladder.Then the catheter was removed at 7:25 p.M.To perform a voiding trial, but as a result of it the patient could not urinate.Therefore, at 10.00 p.M.Again a second catheter (bardex foley catheter size 16 french) was inserted, that second catheter remained in place until 8:00 a.M.On (b)(6) 2020.It was stated that 300cc of saline was injected through the second catheter into plaintiff's bladder and then the second catheter was removed at 8:05 a.M.For another voiding trial, which was successful, and they noted that the second catheter intact when removed.On (b)(6) 2020, during the post-operative visit.The patient had sharp abdominal pain.The physician believed that they had a urinary tract infections and prescribed antibiotics.On (b)(6) 2020, the patient underwent a cystoscopy, as a result it was found what appeared to be bladder stones.To remove the bladder stones on (b)(6) 2020, the patient underwent a surgery but what was removed were not only bladder stones but also a foreign body consisting of a tubular shaped tan piece of plastic measuring 1.5 x 0.5 x 0.1 cm.They believe that this foreign body was a piece of one of the bardex foley catheter.It was also stated that the patient has no history of having a catheter prior to the first catheter.Also, they allege that the piece of the catheter attributed to a urinary tract infection and development of bladder stones.According to this, a piece of one of the catheters broke off and remained inside the patient¿s bladder for many months until it was removed in dec2020.Per additional information received on 13apr2023, it was reported that the pre-july 2020 conditions.Patient underwent gallbladder surgery at age 19.Recalls having had a catheter inserted and removed for that procedure.Recalled no complications from this surgery.No pain listed as a symptom before her july 2020 procedure.Symptoms leading to their bladder swing procedure in july 2020 were incontinence/leakage when exercising and performing basic tasks.They tried medication and performed exercises to try and diminish the leakage but none of this worked.In july 2020 procedure, plaintiff was asleep when the first catheter was inserted.This was the catheter identified in the medical records as a bardex 16 fr.Plaintiff woke up, and recalled shortly after that nurse tried to fill their catheter to perform a voiding trial.Plaintiff heard a ¿pop¿ and felt a ¿pop¿ as this was attempted.Plaintiff claims that heard the pop as well.Plaintiff recall asking the nurse if everything was going to be ok with their bladder swing.The nurse told them everything would be fine.Plaintiff did not ask the nurse if they also heard the ¿pop¿ and it was unclear whether the nurse understood what plaintiff was referring to when they asked if everything was going to be ok with their bladder swing.And they were being unable to void after the first catheter was removed.Plaintiff did not see the nurse remove the catheter because the catheter was covered with a blanket and did not see any packaging for the first catheter and did not know the brand name or manufacturer of the first catheter.Plaintiff testified their pain during and after the catheter removal and insertion was constant, and was about a 5/10.Plaintiff did not see anything to indicate the catheter had broken and they were awake for the insertion and removal of the second catheter.Plaintiff claimed nurse inserted the second catheter and could not describe any packaging for the second catheter and did not know the brand name/manufacturer of the second catheter.Also they could not describe the color of the catheter, but generally was able to describe what a catheter looked like and did not see anything to indicate the catheter had broken and they were able to void after the removal of this catheter.The second nurse, nurse serrano was with plaintiff when they voided after the insertion and removal of this catheter.In pain post-surgery, plaintiff testified that they were in pain longer than expected.Plaintiff thought that their pain would last only 1-2 days, but they also testified that no one told that their post-op pain would last only 1-2 days.In fact, their doctor had written a note to say that would not return to work until september, and doctor told plaintiff that her recovery would take about 4 weeks.Plaintiff confirmed that they determined their pain was lasting longer than it should have in or around mid-september.Plaintiff¿s major complaints were that they could no longer exercise, take their children to school, engage in intercourse and that they had difficulty working.Plaintiff confirmed that they had engaged in intercourse after the surgery but experienced pain during and after intercourse.Also confirmed that the medical records indicating that they stopped having intercourse in or around november were likely accurate.Plaintiff testified that they suffer from depression, and her depression became very bad in 2020 due to covid-19, other personal matters, and because they could not understand why they were in pain.In (b)(6) 2020 surgery, plaintiff met with doctor in december 2020.On or around (b)(6) 020, doctor took images through a scope which confirmed plaintiff had bladder stones.The yellow object that plaintiff produced was confirmed by plaintiff to be a bladder stone discovered on the (b)(6) 2020 hospital visit.Plaintiff had bladder stone removal on (b)(6) 2020 and could not recall whether their procedure involved the insertion or removal of a catheter, but they speculated that it did not because they did not had to perform a voiding trial like they did with the prior surgery.They went to a different hospital for this procedure and overheard the two nurses who were assigned to help their after surgery discussing a broken piece of catheter that was found when the bladder stones were removed.No one else was with plaintiff after this procedure because of covid-19 restrictions.Plaintiff did not ask the nurses follow up questions about the catheter tip.Plaintiff discussed the conversation with doctor did not independently bring this up.They dismissed their concerns and sent them home with pathology findings from their bladder stone surgery.Plaintiff claims that they discovered the existence of the catheter tip from those records.Plaintiff did not raise the pathology findings with doctor in their follow up meeting and testified that if this had been an issue they figured would had raised it with them.In pain post-surgery, plaintiff confirmed that immediately after this surgery the patient was pain free.
|
| |
|
Search Alerts/Recalls
|
|
|
