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

Model Number 165820

Device Problems Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the foley catheter was inserted in or and during post operative day 1, the patient was up for a walk and the foley fell out.Per foley catheter inspection, it was found that there was a split on the balloon part of the foley catheter.Also, it was found that the problem was recurring.It was further reported that the balloon's pieces appear to be intact, no missing pieces.

Manufacturer Narrative

Upon further review, bd/bard has determined that this event is not reportable as it is a duplicate record and was previously reported.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.H3 other text : the device was not returned.

Event Description

It was reported that the foley catheter was inserted in or and during post operative day 1, the patient was up for a walk and the foley fell out.Per foley catheter inspection, it was found that there was a split on the balloon part of the foley catheter.And also it was found that the problem was recurring.It was further reported that the balloon's pieces appear to be intact, no missing pieces.

• Brand Name: BARDEX 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: 10308709
• MDR Text Key: 200850123
• Report Number: 1018233-2020-04694
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029776
• UDI-Public: (01)00801741029776
• 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: 07/31/2020

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 Model Number: 165820
• Device Catalogue Number: 165820
• Device Lot Number: NGDZ1463
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1