MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® UNIVERSAL CATHETERIZATION TRAY

Model Number	792100
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
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 catheter tray (792100) was in a case of intermittent catheter trays (770715).
Event or Problem Description
It was reported that the catheter tray (792100) was in a case of intermittent catheter trays (770715).
Additional Manufacturer Narrative
The reported event was inconclusive due to a poor sample condition, and since there was not enough information to confirm that the tray was received within a box of 770715.Visual evaluation of the returned sample noted one unopened latex intermittent catheter tray with the product catalog number 792100 and lot number ngcw3098.It was noted that the outer case with the labeling of the 770715 tray and 770715 trays within the case were not returned.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Open lubrication-lubricate catheter.".

• Brand Name: BARD® UNIVERSAL CATHETERIZATION TRAY
• Common Device Name: TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8342688
• Report Number: 1018233-2019-00805
• Device Sequence Number: 2229147
• Product Code: OHR
• UDI-Device Identifier: 00801741029646
• UDI-Public: (01)00801741029646
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 07/31/2021
• Device Model Number: 792100
• Device Catalogue Number: 792100
• Device Lot Number: NGCW3098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1