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

Model Number	166818
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2020
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 short supplied of 1 unit for the box of 12 units bardex was delivered to ummi surgical.
Event or Problem Description
It was reported that short supplied of 1 unit for the box of 12 units bardex was delivered to ummi surgical.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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.

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10454331
• Report Number: 1018233-2020-05459
• Device Sequence Number: 16866266
• Product Code: GBM
• UDI-Device Identifier: 00801741029813
• UDI-Public: (01)00801741029813
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 166818
• Device Catalogue Number: 166818
• Device Lot Number: NGDYR545
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1