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

Catalog Number	139005
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the connector of the ureteral catheter did not lock even when turned.
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.
Event or Problem Description
It was reported that the connector of the ureteral catheter did not lock even when turned.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.The product had caused the reported failure.Based on the evaluation, it was observed that the touhy borst adaptor did not lock well even when turned and the tiger tails can move.There were no abnormalities at connector of touhy borst.The exact cause on how and when problem occurred could not be determined.A potential root cause for this failure could be defective components from supplier or can contributed by user related during product handling.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: ¿direction for use 1.Method of use dispense after single use and do not reuse since the device is a disposable product intended only for single use.2.Precaution of use 1) inserting the ureteral catheter, especially without the stabilizing support of a guidewire, be aware that ta 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 tip portion of the catheter become detached, consider retrieval with an endourology grasping device 2) do not withdraw ureteral catheter while it is deflected in endoscopy.It is possible that the catheter may dissected or fracture.3) avoid sharp bending 4) do not over-tighten the catheter adapter.Over-tightening the catheter adapter may occlude the lumen of the catheter.¿ 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.

• Brand Name: BARD® TIGERTAIL¿ FLEXIBLE TIP URETERAL CATHETERS
• Common Device Name: URETERAL CATHETERS
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17540865
• Report Number: 1018233-2023-06074
• Device Sequence Number: 17820798
• Product Code: KOD
• UDI-Device Identifier: 10801741127097
• UDI-Public: (01)10801741127097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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 Catalogue Number: 139005
• Device Lot Number: MYGX4305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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