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

Model Number 0168L12

Device Problems Inflation Problem (1310); Failure to Infuse (2340)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2020

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 it was difficult to inflate during pretest.

Manufacturer Narrative

The reported event was confirmed as design-related.An amber lubricath foley was returned without its original packaging.The balloon was attempted to be inflated with 10cc of water using a leur lock syringe.The inflation funnel began to balloon instead of infusing into the balloon.The catheter valve was cut to find the occlusion area.Water was attempted to be infused using a slip tip syringe with no success.The funnel was cut closer to the shaft and water was able to be infused using the same syringe.No occlusion material was seen.The issue appears to be isolated to upper portion of the inflation funnel.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: "-warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.-valve type: use luer slip tip syringe.Do not use needle.-recommended inflation capacities:5cc balloon: use 10ml sterile water.-visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that it was difficult to inflate during pretest.Per additional information from the investigator via email 23may2020; upon evaluation of the sample it was found that the inner lumen of the inflation funnel was collapsed.

• 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: 9923425
• MDR Text Key: 187386418
• Report Number: 1018233-2020-02355
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017803
• UDI-Public: (01)00801741017803
• 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: 07/29/2020

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
• Device Operator: Health Professional
• Device Model Number: 0168L12
• Device Catalogue Number: 0168L12
• Device Lot Number: MCDV2508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1