MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER; URETHRAL CATHETER TRAY

Model Number	772514
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 tip of the catheter inside of the urethral catheter tray was damaged.
Event or Problem Description
It was reported that the tip of the catheter inside of the urethral catheter tray was damaged.
Additional Manufacturer Narrative
The reported event is confirmed.Visual evaluation of the returned sample noted one opened (without original packaging) vinyl intermittent catheter.It was noted that the catheter tip seemed to be heavily distorted and twisted at the catheter tip.The tip is incompletely formed with both a bent and stretched appearance.Distorted catheter tips that prevent tip smoothness are out of specification.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be out of parameters.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.".

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: URETHRAL CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8428490
• Report Number: 1018233-2019-01364
• Device Sequence Number: 239898
• Product Code: KOD
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/03/2019

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: 772514
• Device Catalogue Number: 772514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1