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

Model Number	772417
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
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 stated it contained three iodine swab sticks.Once opened; it was noted that the kit contained cotton balls and tongs and did not include the liquid iodine.Per review of the catalog, cotton balls are not included in the contents.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.However, the reported event was unconfirmed, as the product lot number was part of the deviation waiver 03-2018-033 which indicated that the product does not contain iodine swabs, and include forceps, rayon balls, and a orange sticker placed to address this to the end user.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: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use." 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.
Event or Problem Description
It was reported that the kit stated it contained three iodine swab sticks.Once opened; it was noted that the kit contained cotton balls and tongs and did not include the liquid iodine.Per review of the catalog, cotton balls are not included in the contents.No medical intervention was reported.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER
• Common Device Name: CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8713773
• Report Number: 1018233-2019-03221
• Device Sequence Number: 1685329
• Product Code: KOD
• UDI-Device Identifier: 00801741030437
• UDI-Public: (01)00801741030437
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Model Number: 772417
• Device Catalogue Number: 772417
• Device Lot Number: NGCV1200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1