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

Model Number 166820

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2017

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 tip of the catheter broke off.This was the second incident with this product.It was later reported, the lumen of the balloon had detached from the catheter, outside of the patient.

Manufacturer Narrative

The reported issue was confirmed.The device was returned for evaluation.Visual inspection observed a mushroom shaped balloon and that the catheter had the inflation arm broken and totally disconnected.No others defects were observed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the tip of the catheter broke off.This was the second incident with this product.It was later reported, the lumen of the balloon detached from the catheter, outside of the patient.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7213831
• MDR Text Key: 98300654
• Report Number: 1018233-2018-00216
• Device Sequence Number: 1
• Product Code: GBM
• UDI-Device Identifier: 00801741029820
• UDI-Public: (01)00801741029820
• Combination Product (y/n): N
• PMA/PMN Number: K760093
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 166820
• Device Catalogue Number: 166820
• Device Lot Number: NGAU2862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1