MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

Catalog Number	154006
Medical Device Problem Codes	Nonstandard Device (1420); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 or Problem Description
It was reported that the patient had been using the 154006-drainage bag as well as the hollister belly bag for their stoma.They had been connecting the bard bag to the bottom of the hollister bag.They brought a new night time drainage bag (154006).When they came back and got ready to change the hollister bag out, there was a purple ring around their stoma on their skin.(lot# nghs2501) (lot# nghs0129) they said it was itchy but was not painful and it did not hurt.It was not there prior to them leaving.They have been to the doctor's office, the doctor did not see them, but they saw a nurse practitioner and an lpn.They did put them on 3 days worth of antibiotics.They advised them to go to this pouch store that sold these sorts of products for stomas.There, they had an appointment set up with a urostomy nurse next week.They had been on the phone for 2hours and 15minutes trying to get some help.They had already spoke with hollister who said they were not familiar with anyone with this problem.They had item 154006 connected to their urostomy bag.They had noticed that the drainage bag seemed to be causing the urostomy bag to collapse (lot# nghs2501) (lot# nghs0129).When they connect this bag at night, it seemed to collapse the hollister bag and drained the urine out- like it was supposed to.What it sounded like to them was it was pulling the skin when the urine was drained out.The purple area did not extend past the wafer.This was the first time this had happened.They had been using these bags since they got out of the hospital.They just wanted to make sure that this was reported in case bd heard of this before.Representative stated that bd drainage bags were single use only.Also advised if this bag was causing any issue to cease using product to prevent any further damage to the skin.Strongly cautioned of signs and symptoms of compromised tissue such as increased redness/purple area, rash, petechiae, or pain at the site.In the event the symptoms escalated, urged to seek immediate care such as an urgent care or if more advanced to the emergency room to prevent the problem from escalating.Per follow up via phone on 23oct2023, patient used product 154006 and a hollister brand bag for a stoma due to removal of the bladder.Customer was given bags from urologist.Customer changed patient's bag 154006 after three weeks and put on a new bag while traveling.Upon reaching destination, customer changed both the hollister brand bag and product 154006 and noticed a purple ring of dots (reaction) around their stoma.No medical intervention was required.Customer stated the rash looked like a suction effect.They had been using lots nghs2501 and nghs0129, but unsure of which lot caused the issue specifically as sample was not saved.
Event or Problem Description
It was reported that the patient had been using the 154006-drainage bag as well as the hollister belly bag for their stoma.They had been connecting the bard bag to the bottom of the hollister bag.They brought a new night time drainage bag (154006).When they came back and got ready to change the hollister bag out, there was a purple ring around their stoma on their skin.(lot# nghs2501) (lot# nghs0129) they said it was itchy but was not painful and it did not hurt.It was not there prior to them leaving.They have been to the doctor's office, the doctor did not see them, but they saw a nurse practitioner and an lpn.They did put them on 3 days worth of antibiotics.They advised them to go to this pouch store that sold these sorts of products for stomas.There, they had an appointment set up with a urostomy nurse next week.They had been on the phone for 2hours and 15minutes trying to get some help.They had already spoke with hollister who said they were not familiar with anyone with this problem.They had item 154006 connected to their urostomy bag.They had noticed that the drainage bag seemed to be causing the urostomy bag to collapse - lot# nghs2501 and lot# nghs0129.When they connect this bag at night, it seemed to collapse the hollister bag and drained the urine out- like it was supposed to.What it sounded like to them was it was pulling the skin when the urine was drained out.The purple area did not extend past the wafer.This was the first time this had happened.They had been using these bags since they got out of the hospital.They just wanted to make sure that this was reported in case bd heard of this before.Representative stated that bd drainage bags were single use only.Also advised if this bag was causing any issue to cease using product to prevent any further damage to the skin.Strongly cautioned of signs and symptoms of compromised tissue such as increased redness/purple area, rash, petechiae, or pain at the site.In the event the symptoms escalated, urged to seek immediate care such as an urgent care or if more advanced to the emergency room to prevent the problem from escalating.Per follow up via phone on (b)(6) 2023, patient used product 154006 and a hollister brand bag for a stoma due to removal of the bladder.Customer was given bags from urologist.Customer changed patient's bag 154006 after three weeks and put on a new bag while traveling.Upon reaching destination, customer changed both the hollister brand bag and product 154006 and noticed a purple ring of dots (reaction) around their stoma.No medical intervention was required.Customer stated the rash looked like a suction effect.They had been using lots nghs2501 and nghs0129, but unsure of which lot caused the issue specifically as sample was not saved.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "materials of construction are not biocompatible".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: "instructions for use: visually inspect the product for any defects or surface deterioration before use.If any package is open, damaged, or if you notice any defect or surface deterioration, do not use.Remove the protective cap from the drainage tube catheter adapter and connect the drainage tube to the catheter.Unhook.Place the hanger on the bed rail near the foot of the bed using a string or hook.Use the sheet clip to secure the drain tube to the sheet.Important: hang the drainage tube straight from the side of the bed to the drainage bag.To empty the bag: open - with your thumb on top of the device and your finger under the green lever, lift and turn counterclockwise."close - with thumb on the green lever and finger on the lever support bar, rotate the lever is clockwise.Note: if a sample is required, see directions for using the urine sample port.Periodic observations of this system should be made to ensure flow urine freely.If a persistent column of urine is observed, check the correct position of the bag then check for a physical obstruction.If the correct position is not determined or the physical obstruction is removed to allow free flow, the bag may need to be changed.After use, this product may pose a potential biological hazard, which must be handled and disposed of in accordance with accepted medical practices and applicable local, state, and federal laws and regulations.Directions for using the bard® ez-lok® sampling port: accept bard® ez-lok® sampling port luer-lock syringe or slide-tip syringe.Connect the drainage tube at least 3 inches below the sampling port until urine is visible below the site access.Wipe the site surface with a disinfectant wipe.Using aseptic technique, place the syringe in the center of the sampling port.Ought to the syringe is perpendicular to the surface of the sampling port (at an angle of approximately 80-100 degrees).Click press the syringe firmly and twist it gently to lock the syringe onto the sampling port.Note: improper penetration technique can cause droplet formation urine on the surface of the sampling port.Regular port monitoring is recommended take samples.4.Aspirate the required volume of urine.5.Unscrew the tubes and send the sample to the laboratory.Directions for draining the urine measuring device: if the bag is not positioned correctly, urine may bypass the meter and go directly into the bag.Replace the bag as necessary.The urine measuring device can be emptied in two ways: a.To empty it into the bag, hold the bottom of the meter and lift it up.To provide better drainage of the meters, it is recommended to raise them again.B.To empty the urine meter into the container, twist off the green part of the drain valve to the left; to close, turn the green position of the drain valve to the right.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some medical devices polyvinyl chloride.Dehp has been shown to produce a range of harmful effects in animals experiments, particularly liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp has been well demonstrated in experimental animals, but the ability of this compound to cause harmful effects on.Humans are controversial.There is no evidence that it is suitable for neonates, infants and pregnant women breastfeeding women exposed to dehp experience no relevant adverse effects.However, the lack of evidence the causal relationship between dehp-pvc and any disease or adverse effect does not mean there is no risk." correction: b,f,h.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the patient had been using the 154006-drainage bag as well as the hollister belly bag for their stoma.They had been connecting the bard bag to the bottom of the hollister bag.They brought a new night time drainage bag (154006).When they came back and got ready to change the hollister bag out, there was a purple ring around their stoma on their skin.(lot# nghs2501) (lot# nghs0129) they said it was itchy but was not painful and it did not hurt.It was not there prior to them leaving.They have been to the doctor's office, the doctor did not see them, but they saw a nurse practitioner and an lpn.They did put them on 3 days worth of antibiotics.They advised them to go to this pouch store that sold these sorts of products for stomas.There, they had an appointment set up with a urostomy nurse next week.They had been on the phone for 2hours and 15minutes trying to get some help.They had already spoke with hollister who said they were not familiar with anyone with this problem.They had item 154006 connected to their urostomy bag.They had noticed that the drainage bag seemed to be causing the urostomy bag to collapse - lot# nghs2501 and lot# nghs0129.When they connect this bag at night, it seemed to collapse the hollister bag and drained the urine out- like it was supposed to.What it sounded like to them was it was pulling the skin when the urine was drained out.The purple area did not extend past the wafer.This was the first time this had happened.They had been using these bags since they got out of the hospital.They just wanted to make sure that this was reported in case bd heard of this before.Representative stated that bd drainage bags were single use only.Also advised if this bag was causing any issue to cease using product to prevent any further damage to the skin.Strongly cautioned of signs and symptoms of compromised tissue such as increased redness/purple area, rash, petechiae, or pain at the site.In the event the symptoms escalated, urged to seek immediate care such as an urgent care or if more advanced to the emergency room to prevent the problem from escalating.Per follow up via phone on (b)(6) 2023, patient used product 154006 and a hollister brand bag for a stoma due to removal of the bladder.Customer was given bags from urologist.Customer changed patient's bag 154006 after three weeks and put on a new bag while traveling.Upon reaching destination, customer changed both the hollister brand bag and product 154006 and noticed a purple ring of dots (reaction) around their stoma.No medical intervention was required.Customer stated the rash looked like a suction effect.They had been using lots nghs2501 and nghs0129, but unsure of which lot caused the issue specifically as sample was not saved.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "vent wets out due to exposure to urine, stool, etc.".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "instructions for use: visually inspect the product for any defects or surface deterioration before use.If any package is open, damaged, or if you notice any defect or surface deterioration, do not use.1.Remove the protective cap from the drainage tube catheter adapter and connect the drainage tube to the catheter.2.Unhook.3.Place the hanger on the bed rail near the foot of the bed using a string or hook.4.Use the sheet clip to secure the drain tube to the sheet.Important: hang the drainage tube straight from the side of the bed to the drainage bag.5.To empty the bag: open - with your thumb on top of the device and your finger under the green lever, lift and turn counterclockwise."close - with thumb on the green lever and finger on the lever support bar, rotate the lever is clockwise.Note: if a sample is required, see directions for using the urine sample port.6.Periodic observations of this system should be made to ensure flow urine freely.If a persistent column of urine is observed, check the correct position of the bag then check for a physical obstruction.If the correct position is not determined or the physical obstruction is removed to allow free flow, the bag may need to be changed.7.After use, this product may pose a potential biological hazard, which must be handled and disposed of in accordance with accepted medical practices and applicable local, state, and federal laws and regulations.Directions for using the bard® ez-lok® sampling port: accept bard® ez-lok® sampling port luer-lock syringe or slide-tip syringe.1.Connect the drainage tube at least 3 inches below the sampling port until urine is visible below the site access.2.Wipe the site surface with a disinfectant wipe.3.Using aseptic technique, place the syringe in the center of the sampling port.Ought to the syringe is perpendicular to the surface of the sampling port (at an angle of approximately 80-100 degrees).Click press the syringe firmly and twist it gently to lock the syringe onto the sampling port.Note: improper penetration technique can cause droplet formation urine on the surface of the sampling port.Regular port monitoring is recommended take samples.4.Aspirate the required volume of urine.5.Unscrew the tubes and send the sample to the laboratory.Directions for draining the urine measuring device: if the bag is not positioned correctly, urine may bypass the meter and go directly into the bag.Replace the bag as necessary.The urine measuring device can be emptied in two ways: a.To empty it into the bag, hold the bottom of the meter and lift it up.To provide better drainage of the meters, it is recommended to raise them again.B.To empty the urine meter into the container, twist off the green part of the drain valve to the left; to close, turn the green position of the drain valve to the right.Di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some medical devices polyvinyl chloride.Dehp has been shown to produce a range of harmful effects in animals experiments, particularly liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp has been well demonstrated in experimental animals, but the ability of this compound to cause harmful effects on.Humans are controversial.There is no evidence that it is suitable for neonates, infants and pregnant women breastfeeding women exposed to dehp experience no relevant adverse effects.However, the lack of evidence the causal relationship between dehp-pvc and any disease or adverse effect does not mean there is no risk." section a through f - the information provided by bd represents all 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.

• Brand Name: BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: URINARY DRAINAGE BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18133672
• Report Number: 1018233-2023-08111
• Device Sequence Number: 15382335
• Product Code: KNX
• UDI-Device Identifier: 00801741029615
• UDI-Public: (01)00801741029615
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 154006
• Device Lot Number: NGHS2501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 01/03/2024; 04/03/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/04/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown