MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER FOLEY TRAY WITH BARDEX® LUBRICATH FOLEY CATHETER; COUDE CATHETER

Model Number	892816
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
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 the catheter balloon inflated improperly only on one side during a pretest of the balloon.The catheter tip was not flexible and was rigid.It was not used on the patient.
Event or Problem Description
It was reported the catheter balloon inflated improperly only on one side during a pretest of the balloon.The catheter tip was not flexible and was rigid.It was not used on the patient.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.

• Brand Name: BARD® URINE METER FOLEY TRAY WITH BARDEX® LUBRICATH FOLEY CATHETER
• Common Device Name: COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9250581
• Report Number: 1018233-2019-06879
• Device Sequence Number: 1985222
• Product Code: EZC
• UDI-Device Identifier: 00801741046056
• UDI-Public: (01)00801741046056
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 892816
• Device Catalogue Number: 892816
• Device Lot Number: NGDN0758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1