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

Model Number 0168L16

Device Problems Burst Container or Vessel (1074); Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that urine leaked due to the balloon burst.It was also stated that there was a white speckled pattern on the catheter.As per additional information received via email on 28 aug 2020 from ibc representative, there were no missing pieces and there was no medical intervention reported.

Event Description

It was reported that urine leaked due to the balloon burst.It was also stated that there was a white speckled pattern on the catheter.As per additional information received via email on 28aug2020 from ibc representative, there were no missing pieces and there was no medical intervention reported.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.The foley balloon was found to be burst (gross visual evaluation).A potential root cause could be due to " cuff wall thickness too thin.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.As only the catheter subassembly was returned without a tray number or a corporate lot, it cannot be determined the labeling this catheter was sold in.However, 2 labeling reviews were performed, and were deemed adequate as it states the following: "warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." "be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.]" 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.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER COUDE TIP
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10536424
• MDR Text Key: 207933019
• Report Number: 1018233-2020-05924
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017827
• UDI-Public: (01)00801741017827
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: 0168L16
• Device Catalogue Number: 0168L16
• Device Lot Number: MCCZ2967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1