MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® TIGERTAIL¿ FLEXIBLE TIP URETERAL CATHETERS; URETHRAL CATHETER

Catalog Number	139005
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 a failure in the bard polyurethane ureteral catheter ref # 139005rt flexible tip 5 fr x 70cm lot # rekn1298 exp 02/28/2029 on 7/27/25.This catheter tip about 2 cm long broke during surgery but was retrieved during the case with no adverse effect.
Event or Problem Description
It was reported a failure in the bard polyurethane ureteral catheter ref # (b)(4) flexible tip 5 fr x 70cm lot # rekn1298 exp 02/28/2029 on 7/27/25.This catheter tip about 2 cm long broke during surgery but was retrieved during the case with no adverse effect.Per additional information received via email on 03sep2025, it was reported that the sample was unable to release.If someone wants to view, can come on site.And stated foreign body was able to retrieve with basket from patient body.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it states: "warning: this unit should not be used as a ureteral splint.Warning: this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: do not withdraw ureteral catheter while it is deflected in endoscope.Avoid sharp bending.Caution: do not over-tighten the catheter adapter.Over-tightening the catheter adapter may occlude the lumen of the catheter.Caution: when using the tigertail catheter without the stabilizing support of a guidewire, be aware that a malfunction may occur where the flexible tip may detach if excessive force is made in contact with the walls of the bladder, ureter or renal pelvis.Should the flexible portion of the catheter become detached, retrieve with an endourology grasping device." a review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Corrections: d, e.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® TIGERTAIL¿ FLEXIBLE TIP URETERAL CATHETERS
• Common Device Name: URETHRAL CATHETER
• 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22883284
• Report Number: 1018233-2025-06999
• Device Sequence Number: 12977067
• Product Code: KOD
• UDI-Device Identifier: 10801741127097
• UDI-Public: (01)10801741127097(11)250130(17)290228(10)REKN1298
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K033719
• 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
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 139005
• Device Lot Number: REKN1298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2025
• 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; Required Intervention
• Patient Sex: Unknown