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

Model Number	136405
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ureteral catheter might have broken inside patient.Per sample received on (b)(6) 2023, customer returned an additional used sample.
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 ureteral catheter might have broken inside patient.Per sample received on 05jun2023, customer returned an additional used sample.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The product was used for patient treatment.The ureteral catheter was returned with the original packaging.A portion of the catheter was noted to have been broken off at an angle, the broken piece was not returned.The total length of the catheter was found to be 70.4cm, the broken portion separated at the 70.1cm mark on the device; therefore, the broken piece appears to measure 0.3cm.A potential root cause for this failure mode could be ¿inadequate joint strength¿.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: "caution: do not withdraw ureteral catheter while it is deflected in endoscope.Avoid sharp bending." 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 ureteral catheter might have broken inside patient.Per sample received on 05jun2023, customer returned an additional used sample.Per follow up via mail on 09jun2023, customer said that there was no harm to patient.
Additional Manufacturer Narrative
The reported event was confirmed and the cause was unknown.A potential root cause for this failure mode could be ¿inadequate joint strength¿.1 sample were confirmed to exhibit the reported failure.The product was used for patient treatment.The ureteral catheter was returned with the original packaging.A portion of the catheter was noted to have been broken off at an angle, the broken piece was not returned.The total length of the catheter was found to be 70.4cm, the broken portion separated at the 70.1cm mark on the device; therefore, the broken piece appears to measure 0.3cm.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: "caution: do not withdraw ureteral catheter while it is deflected in endoscope.Avoid sharp bending." 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.

• Brand Name: BARD® POLYURETHANE URETERAL CATHETERS, WHISTLE TIP
• Common Device Name: POLYURETHANE URETERAL CATHETERS, WHISTLE TIP
• 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: 17105724
• Report Number: 1018233-2023-04196
• Device Sequence Number: 16852544
• Product Code: EYB
• UDI-Device Identifier: 10801741126977
• UDI-Public: (01)10801741126977
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2024

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: Lay User/Patient
• Device Expiration Date: 11/30/2025
• Device Model Number: 136405
• Device Catalogue Number: 136405
• Device Lot Number: REFS4490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 05/21/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 10/13/2023; 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• 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