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

Model Number	123528A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9922649
• Report Number: 1018233-2020-02343
• Device Sequence Number: 14155153
• Product Code: EZC
• UDI-Device Identifier: 00801741095153
• UDI-Public: (01)00801741095153
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1