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

Catalog Number 1758SI16

Device Problems Break (1069); Crack (1135); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2019

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 urine leaked from a crack on the catheter.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with a cut portion of inlet tubing and attached sample port connector.Visual inspection of the catheter surface noted no visible defects.The catheter balloon was inflated with 10ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) which leaked from a hole (0.1650") in the drainage lumen 0.4085" from the bifurcation.The catheter was confirmed to be 16 fr.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: ¿be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petroleum and animal oils).[they may damage the device and may burst balloon.]".

Event Description

It was reported that urine leaked from a crack on the catheter.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8359666
• MDR Text Key: 137184642
• Report Number: 1018233-2019-00952
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

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: 11/02/2022
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGBX2063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1