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

Model Number	139005
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the width was not consistent throughout the tiger tail catheter and the wire got stuck and the staff had to cut the catheter to remove it.There was no patient harm, and the physician feels this was not the first time he has had this occur.
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 the width was not consistent throughout the tiger tail catheter and the wire got stuck, and the staff had to cut the catheter to remove it.There was no patient harm, and the physician feels this was not the first time he has had this occur.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation and further investigation was not conclusive.As the specific cause for this event cannot be determined, a potential cause for this event could be, "incorrect mfg.Methods used tip not manufactured to specifications".The device was used for treatment purposes.It is unknown if the device had met all relevant specifications or resulted in the reported event.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.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.

• 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: 16295419
• Report Number: 1018233-2023-00600
• Device Sequence Number: 20696847
• Product Code: KOD
• UDI-Device Identifier: 10801741127097
• UDI-Public: (01)10801741127097
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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 Expiration Date: 08/31/2026
• Device Model Number: 139005
• Device Catalogue Number: 139005
• Device Lot Number: REGR2725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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