MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER COUDE TIP; 5CC LUBRICATH

Model Number 0165L16

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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

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 while adding lubricant to the catheter, the catheter broke in half.

Manufacturer Narrative

The reported event was confirmed.A photo sample was sent of an amber latex foley catheter.The catheter did appear to have lubricant at the edge the catheter appeared to have a bagger cut along the middle of the shaft.This is indicative of a manufacturing failure that would occur in bulk packaging process.This product would have failed specifications via inspection procedure.The root cause for this failure is an "operator error" when verifying speed or laying the catheter on the marked line of belt.During the bagging machine operation.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.If package is opened or if any imperfection or surface deterioration is observed, do not 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.

Event Description

It was reported that while adding lubricant to the catheter, the catheter broke in half.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER COUDE TIP
• Type of Device: 5CC LUBRICATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9880965
• MDR Text Key: 186711889
• Report Number: 1018233-2020-02116
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017483
• UDI-Public: (01)00801741017483
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

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 Expiration Date: 11/30/2021
• Device Model Number: 0165L16
• Device Catalogue Number: 0168L16
• Device Lot Number: NGDX0217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1