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

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.
Event or Problem Description
It was reported that there was a missing catheter and rayon balls from the catheter tray prior to use.
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 c.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com manufactured in mexico latex-free gloves (2) lubricant graduated collection container pk7631570 08/2010 bard ® urethral catheterization tray 772417 vinyl catheter patient¿s name room number adm.No.Date vinyl catheter 14 fr.Directions for use on reverse side.Single use only.Do not resterilize.For urological use only.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".
Event or Problem Description
It was reported that there was a missing catheter and rayon balls from the catheter tray prior to use.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER
• Common Device Name: CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8026183
• Report Number: 1018233-2018-05104
• Device Sequence Number: 1578749
• Product Code: KOD
• UDI-Device Identifier: 00801741030437
• UDI-Public: (01)00801741030437
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/07/2018

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: 01/31/2021
• Device Model Number: 772417
• Device Catalogue Number: 772417
• Device Lot Number: NGCR0166
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1