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

Model Number	0165L24
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.
Event or Problem Description
It was reported that the interior of the catheter collapsed on the balloon and was not able to drain.The balloon had to be deflated to get the drainage going.The patient has also experienced several bladder infections and stated a full bladder can cause hyperreflexia, which was when the blood pressure could go up uncontrollably in a quadriplegic patient.It was unknown what treatment was provided for the infection per sample evaluation notification from the investigator via email on 15 dec 2020, the catheter was found to be non concentric upon inflating.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment purposes.The product had caused the reported failure.A potential root cause for this failure could be "operator error.Dull cutting tools.".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is manufacturing related.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 actual/suspected device was evaluated.
Event or Problem Description
It was reported that the interior of the catheter collapsed on the balloon and was not able to drain.The balloon had to be deflated to get the drainage going.The patient has also experienced several bladder infections and stated a full bladder can cause hyperreflexia, which was when the blood pressure could go up uncontrollably in a quadriplegic patient.It was unknown what treatment was provided for the infection per sample evaluation notification from the investigator via email on 15dec2020,the catheter was found to be non concentric upon inflating per follow up via email on 07feb21, the balloon was filled with approximately 5 cc or less of sterile water provided in the catheter change kit, as research had shown this helps in preventing bladder damage.Doctor had prescribed bactrim for bladder infections.It was also stated that this was a serious problem not only happening to customer' son but also with other people, as reported to craig hospital's urology department.This hospital specializes in spinal cord injuries and all aspects of care resulting from a spinal cord injury.Also stated that their son had been using them since an injury in 1990 and this was their first experience with catheter failures.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11127511
• Report Number: 1018233-2020-22363
• Device Sequence Number: 19769374
• Product Code: EZC
• UDI-Device Identifier: 00801741017520
• UDI-Public: (01)00801741017520
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2025
• Device Model Number: 0165L24
• Device Catalogue Number: 0165L24
• Device Lot Number: NGES4065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other