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

Model Number	772417
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.The device was not returned.
Event or Problem Description
It was reported that the kit was missing iodine.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿missing components/ accessories and/or not according to proper assembly sequence¿ with a potential root cause of ¿incorrect operation¿.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: "contents: vinyl catheter, 14 fr.Uro-prep¿ tray with: underpad, drape, povidone-iodine swabsticks (3), specimen container and label.".
Event or Problem Description
It was reported that the kit was missing iodine.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER
• Common Device Name: URETH TRAY WITH VINYL GLOVES
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9447487
• Report Number: 1018233-2019-07848
• Device Sequence Number: 502111
• Product Code: KOD
• UDI-Device Identifier: 00801741030437
• UDI-Public: (01)00801741030437
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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: 772417
• Device Catalogue Number: 772417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1