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

Model Number 0168L14

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 02/18/2020

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 the tip of catheter was found broken prior to use.

Event Description

It was reported that the tip of catheter was found broken prior to use.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.An amber lubricath foley catheter was returned with its tip missing.The tip appeared to be torn/cut off.Moncks corner quality confirmed the failure to be a bagger cut.The root cause of this failure is operator error in placing the catheter too far away from the marked line on the belt during the bagging process due to which the tip got cut off, resulting in an unusable device and replacement of device.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." 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 (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9831850
• MDR Text Key: 185803012
• Report Number: 1018233-2020-01808
• 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: 04/17/2020

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: 01/24/2024
• Device Model Number: 0168L14
• Device Catalogue Number: 0168L14
• Device Lot Number: MCDN4205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1