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

Model Number 0168L14

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

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 water leaked from the bifurcation of the inflation funnel during pretest.Per additional information received from ibc via mail on 18 aug 2020, it seemed that there was a hole on the funnel.

Event Description

It was reported that water leaked from the bifurcation of the inflation funnel during pretest.Per additional information received from ibc via mail on 18aug2020, it seemed that there was a hole on the funnel.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.An amber lubricath foley catheter was returned.The catheter was noted to have a hole in its shaft.The catheter was attempted to be inflated with 10 ccs of di water.Water leaked from a pinhole in the shaft.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: "visually inspect the product for any imperfections or surface deterioration prior to use." 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: 10468591
• MDR Text Key: 206164007
• Report Number: 1018233-2020-05528
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017810
• UDI-Public: (01)00801741017810
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 0168L14
• Device Catalogue Number: 0168L14
• Device Lot Number: NGDT0830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1