MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® UROLOGIST'S TRAY; UROL TRAY

Model Number	123400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 upon opening packaging but before use, the product was melted.
Additional Manufacturer Narrative
The reported event was confirmed, however, the cause is unknown.Visual evaluation of the returned sample noted one opened (no original packaging), middle tray(pv0272) of the urologist tray with minimal contents.It was noted that there was a crack perpendicular to the middle tray edge that went beyond the narrow cavity with two filiform catheters still inside.This does not meet the specification "part shall be free from holes, tears, and cracks" per inspection procedure.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be inappropriate material selection.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: "corrugated shipping case is to be capable of supporting boxes during palletization and warehousing without bursting, bulging, or damaging contents.".H11: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 upon opening packaging but before use, the product was melted.

• Brand Name: BARD® UROLOGIST'S TRAY
• Common Device Name: UROL TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9647825
• Report Number: 1018233-2020-00630
• Device Sequence Number: 3130102
• Product Code: KOE
• UDI-Device Identifier: 00801741000294
• UDI-Public: (01)00801741000294
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

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: 04/30/2022
• Device Model Number: 123400
• Device Catalogue Number: 123400
• Device Lot Number: NGDW3315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 03/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1