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

Catalog Number	123400
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
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.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 device was not returned.
Event or Problem Description
It was reported that the wire in this urologist tray seems to be different.Customer used it for six or seven years now and never had a problem until recently.The wire has been bended in the last three cases that they have used the bard urologist tray.Customer kept had to open different wires.(batch#nggy5965).
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned sample noted one opened (with original packaging), used guide wire.Visual inspection noted wire was bent and the jacket not covering the wire entirely.Further inspection noted the wire is not enclosed within the jacket and was extruded in the opposite direction of the jacket.This does not meet specification which states " units are to be assembled and package as indicated in the layout drawing".A potential root cause for this failure mode could be ¿lack of training - packaging pattern not followed".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labelling could not have prevented the reported failure.Correction: 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.
Event or Problem Description
It was reported that the wire in this urologist tray seems to be different.Customer used it for six or seven years now and never had a problem until recently.The wire has been bended in the last three cases that they have used the bard urologist tray.Customer kept had to open different wires.(batch#nggy5965 and batch#unk ).Per additional information received via form with sample returned on 14nov2023, patients' urologist had stated that the wire that comes in this kit seems to different because it has kinked up on the last 3 times patient had used it.Patient had used this kit for years and this is a new issue.
Event or Problem Description
It was reported that the wire in this urologist tray seems to be different.Customer used it for six or seven years now and never had a problem until recently.The wire has been bended in the last three cases that they have used the bard urologist tray.Customer kept having to open different wires.(batch # nggy5965 and batch # unk).Per additional information received via form with sample returned on 14nov2023, patients' urologist had stated that the wire that comes in this kit seems to be different because it has kinked up on the last 3 times patient had used it.Patient had used this kit for years and this is a new issue.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.Visual evaluation of the returned sample noted one opened (with original packaging), used guide wire.Visual inspection noted wire was bent and the jacket not covering the wire entirely.Further inspection noted the wire is not enclosed within the jacket and was extruded in the opposite direction of the jacket.This does not meet specification states " units are to be assembled and package as indicated in the layout drawing".A labeling review was not performed because labelling could not have prevented the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.Corrections: d, e, f, h.Udi format updated with available product information per gudid.H11: sections 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.

• 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 GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 17876874
• Report Number: 1018233-2023-07175
• Device Sequence Number: 17239824
• Product Code: KOE
• UDI-Device Identifier: 00801741000294
• UDI-Public: (01)00801741000294(11)230119(17)250831(10)NGGY5965
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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: 08/31/2025
• Device Catalogue Number: 123400
• Device Lot Number: NGGY5965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 01/30/2026
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/21/2023; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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