MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER

Catalog Number 0165L16

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2024

Event Type  malfunction  

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 Description

It was reported that customer had couple of concerns about surestep foley catheters they have had recently on their unit.Staffs were reporting that there have been occasions where the balloon did not inflate or deflate on the first, or even second try.Staffs were aware that it was not recommended to blow up the balloon prior to insertion but now that this problem has been discovered were continuing to try it prior to insertion.They were wondered if it did not deflate before they put it in, how could they know it was deflated prior to removal.Stated that the operating room staffs were reporting times that a foley was in place prior to c-section starting but the bladder was full upon opening the abdomen.They have noticed occasionally the bladder was not emptying, even after the baby was born until the foley was manipulated.Per additional information received via email on 28mar2024, it was reported that the earlier in the week a staff member stated that the foley tubing came off the bag as patient was moving it around.Patient was able to reattach and did not save the product.Last week, in the operating room (c-section) the bladder seemed to be fuller than normal with foley in place however the anesthesia team reported foley draining yellow urine.The only specific product they had available was an unused foley that was told that they had problems blowing up the balloon.Now that they had tried several times and played with the product it worked fine.

Event Description

It was reported that customer had couple of concerns about surestep foley catheters they have had recently on their unit.Staffs were reporting that there have been occasions where the balloon did not inflate or deflate on the first, or even second try.Staffs were aware that it was not recommended to blow up the balloon prior to insertion but now that this problem has been discovered were continuing to try it prior to insertion.They were wondered if it did not deflate before they put it in, how could they know it was deflated prior to removal.Stated that the operating room staffs were reporting times that a foley was in place prior to c-section starting but the bladder was full upon opening the abdomen.They have noticed occasionally the bladder was not emptying, even after the baby was born until the foley was manipulated.Per additional information received via email on 28mar2024, it was reported that the earlier in the week a staff member stated that the foley tubing came off the bag as patient was moving it around.Patient was able to reattach and did not save the product.Last week, in the operating room (c-section) the bladder seemed to be fuller than normal with foley in place however the anesthesia team reported foley draining yellow urine.The only specific product they had available was an unused foley that was told that they had problems blowing up the balloon.Now that they had tried several times and played with the product it worked fine.Per ucc notification received via task on 22apr2024, the customer did not return an all-silicone foley catheter.The customer returned a foley catheter attached to a drain bag ( (b)(4) ).

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 Description

It was reported that customer had couple of concerns about surestep foley catheters they have had recently on their unit.Staffs were reporting that there have been occasions where the balloon did not inflate or deflate on the first, or even second try.Staffs were aware that it was not recommended to blow up the balloon prior to insertion but now that this problem has been discovered were continuing to try it prior to insertion.They were wondered if it did not deflate before they put it in, how could they know it was deflated prior to removal.Stated that the operating room staffs were reporting times that a foley was in place prior to c-section starting but the bladder was full upon opening the abdomen.They have noticed occasionally the bladder was not emptying, even after the baby was born until the foley was manipulated.Per additional information received via email on 28mar2024, it was reported that the earlier in the week a staff member stated that the foley tubing came off the bag as patient was moving it around.Patient was able to reattach and did not save the product.Last week, in the operating room (c-section) the bladder seemed to be fuller than normal with foley in place however the anesthesia team reported foley draining yellow urine.The only specific product they had available was an unused foley that was told that they had problems blowing up the balloon.Now that they had tried several times and played with the product it worked fine.Per ucc notification received via task on 22apr2024, the customer did not return an all-silicone foley catheter.The customer returned a foley catheter attached to a drain bag (pcn#0165l16 and pcn#0165l16).

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to drainage eye occlusion blocked drainage lumen caused by plc failure and also might be contribute by no drainage eye or user related (salt accumulation).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: "cdc guidelines for appropriate indications for indwelling urethral catheter use: patient has acute urinary retention or bladder outlet obstruction; need for accurate urine output measurements; use for selected surgical procedures; to assist in healing of open sacral or perineal wounds; patient requires prolonged immobilization; to improve comfort for end of life care.Proper techniques for urinary catheter insertion: perform hand hygiene immediately before and after insertion; insert urinary catheters using aseptic technique and sterile equipment; use the smallest foley catheter possible, consistent with good drainage; document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record.Proper techniques for urinary catheter maintenance: secure the foley catheter.Use the statlock® foley stabilization device if provided; maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions; maintain unobstructed urine flow and keep the catheter and collection tube free from kinking; keep the collection bag below the level of the bladder or hips at all times; empty the collection bag regularly using a separate, clean collection container for each patient.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract." 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 Description

It was reported that customer had couple of concerns about surestep foley catheters they have had recently on their unit.Staffs were reporting that there have been occasions where the balloon did not inflate or deflate on the first, or even second try.Staffs were aware that it was not recommended to blow up the balloon prior to insertion but now that this problem has been discovered were continuing to try it prior to insertion.They were wondered if it did not deflate before they put it in, how could they know it was deflated prior to removal.Stated that the operating room staffs were reporting times that a foley was in place prior to c-section starting but the bladder was full upon opening the abdomen.They have noticed occasionally the bladder was not emptying, even after the baby was born until the foley was manipulated.Per additional information received via email on 28mar2024, it was reported that the earlier in the week a staff member stated that the foley tubing came off the bag as patient was moving it around.Patient was able to reattach and did not save the product.Last week, in the operating room (c-section) the bladder seemed to be fuller than normal with foley in place however the anesthesia team reported foley draining yellow urine (pr# (b)(4)).The only specific product they had available was an unused foley that was told that they had problems blowing up the balloon.Now that they had tried several times and played with the product it worked fine.Per ucc notification received via task on 22apr2024, the customer did not return an all-silicone foley catheter.The customer returned a foley catheter attached to a drain bag (b)(4).

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A potential root cause for this failure could be due to drainage eye occlusion blocked drainage lumen caused by plc failure and also might be contribute by no drainage eye or user related (salt accumulation).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: insert foley catheters only for appropriate indications and leave in place only as long as needed.Cdc guidelines for appropriate indications for indwelling urethral catheter use: ¿ patient has acute urinary retention or bladder outlet obstruction ¿ need for accurate urine output measurements ¿ use for selected surgical procedures ¿ to assist in healing of open sacral or perineal wounds ¿ patient requires prolonged immobilization ¿ to improve comfort for end of life care proper techniques for urinary catheter insertion: - perform hand hygiene immediately before and after insertion - insert urinary catheters using aseptic technique and sterile equipment - use the smallest foley catheter possible, consistent with good drainage - document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record proper techniques for urinary catheter maintenance: - secure the foley catheter.Use the statlock® foley stabilization device if provided - maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions - maintain unobstructed urine flow and keep the catheter and collection tube free from kinking - keep the collection bag below the level of the bladder or hips at all times - empty the collection bag regularly using a separate, clean collection container for each patient * generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.Correction: d,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.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• 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: 19002652
• MDR Text Key: 339208736
• Report Number: 1018233-2024-01693
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017483
• UDI-Public: (01)00801741017483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165L16
• Device Lot Number: MYGZ4189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other