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

Model Number	A303314A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 bardex ic foley catheter leaked from the valve below the balloon port.
Event or Problem Description
It was reported that the bardex ic foley catheter leaked from the valve below the balloon port.
Additional Manufacturer Narrative
Per additional information received, bard medical/bd has determined that this mdr was initially reported in error as this event is not reportable.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Common Device Name: BARDEX IC FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8281943
• Report Number: 1018233-2019-00421
• Device Sequence Number: 19508533
• Product Code: MJC
• UDI-Device Identifier: 00801741073786
• UDI-Public: (01)00801741073786
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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 Model Number: A303314A
• Device Catalogue Number: 0165SI14
• Device Lot Number: NGCT2737
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1