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

Model Number	123400
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2022
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 bard urologist's tray was wet when it arrived and looked like the product had some water damage as well.
Additional Manufacturer Narrative
The reported event is inconclusive due to a lack of information.The urologist's tray was returned unopened.The tray packaging met visual specifications per revision 1.The tray was dry when evaluated, however, one end of the packaging was stained yellow and some areas on the packaging appears as though it may possibly have been wet at one point.The packaging was opened to examine inside; all components were present, the lubricant and sterile water syringes were both intact and no signs of leakage were noted on either syringe or within the tray.Although no sings of leakage was present within the tray and the outer packaging was dry during evaluation, as it is unknown if the product was received by the customer with a wet outer packaging or the packaging got wet during storage by the customer, this event will be inconclusive due to lack of information.A potential root cause for this event could be, "damaged product during shipping".As no patient involvement was reported the device was not used, however, it is intended for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A label/pack review is not required as a review of the label could not have prevented the reported event.Correction: b, d, f, g, h.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the bard urologist's tray was wet when it arrived and looked like the product had some water damage as well.

• Brand Name: BARD® UROLOGIST'S TRAY
• Common Device Name: UROLOGIST'S TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14167094
• Report Number: 1018233-2022-02764
• Device Sequence Number: 12205128
• Product Code: KOE
• UDI-Device Identifier: 00801741000294
• UDI-Public: (01)00801741000294
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: 04/30/2024
• Device Model Number: 123400
• Device Catalogue Number: 123400
• Device Lot Number: NGGP0463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown