MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA FOLEY CATHETER SILICONE COATED

Model Number 123528A

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2020

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 package was broken.Per additional information from the ibc via email 20mar2020, the package was torn on one end.

Manufacturer Narrative

The reported event was confirmed.Evaluation on photo sample observed tear at side of package.The exact cause of how and when the problem occurred could not be determined.The potential root cause for this failure could be user related / rough handling/ improper storage of the product.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: "sterile unless package has been opened or damaged".

Event Description

It was reported that the package was broken.Per additional information from the ibc via email 20mar2020, the package was torn on one end.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9922649
• MDR Text Key: 187538548
• Report Number: 1018233-2020-02343
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741095153
• UDI-Public: (01)00801741095153
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

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: 10/01/2022
• Device Model Number: 123528A
• Device Catalogue Number: 123528A
• Device Lot Number: MYBZR923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Initial Date Manufacturer Received: 03/12/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1