MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; LUBRISIL FOLEY CATHETER

Model Number 175816

Device Problem Break (1069)

Patient Problem 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.The information provided by bard 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 bard.

Event Description

It was reported that the catheter broke at the bifurcation of the urine lumen and the inflation port (y connector).

Event Description

It was reported that the catheter broke at the bifurcation of the urine lumen and the inflation port (y connector).

Manufacturer Narrative

The reported event was confirmed with an unknown cause.Received used 1 foley catheter for evaluation.During the visual evaluation, it was observed that the catheter had the drainage arm broken and totally disconnected.The breakage site had an irregular cut, jagged edges, and no stress marks observed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7145778
• MDR Text Key: 95928569
• Report Number: 1018233-2017-06473
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• 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: 03/06/2018

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: 07/24/2022
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGBU1049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 03/02/2018
• Supplement Dates FDA Received: 03/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1