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

Model Number	772417
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 pvi swabsticks were missing from the tray.Reportedly, there was no yellow sticker on the packaging indicating that the sticks were not in they tray.No medical intervention was reported.
Event or Problem Description
It was reported that the pvi swabsticks were missing from the tray.Reportedly, there was no yellow sticker on the packaging indicating that the sticks were not in they tray.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 latex-free gloves (2) lubricant graduated collection container caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: contents of inner wrap are sterile unless package is opened or damaged.Directions for use on reverse side.Single use only.Do not resterilize.For urological use only." 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.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL 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: 8309889
• Report Number: 1018233-2019-00631
• Device Sequence Number: 2371019
• Product Code: KOD
• UDI-Device Identifier: 00801741030437
• UDI-Public: (01)00801741030437
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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 Expiration Date: 11/30/2021
• Device Model Number: 772417
• Device Catalogue Number: 772417
• Device Lot Number: NGCT0683
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1