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

Catalog Number	134005
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
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.
Event or Problem Description
It was reported that customer ordered product that was listed as a 5fr open tip urethral catheter in replace of 139005 being on bo.When customer received product, a wire would not pass through, the catheter was too small, which it should not have been.Customer cannot use this item.
Additional Manufacturer Narrative
The reported event is inconclusive.Visual evaluation noted received 9 polyurethane ureteral catheters in original closed packaging.Using fr size gauge all returned samples were found to be 5fr size.As the guidewire that was used during the reported event was not returned the reported event is inconclusive.No root cause was provided.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as labelling would have prevented the reported event.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 that customer ordered product that was listed as a 5fr open tip urethral catheter in replace of 139005 being on bo.When customer received product, a wire would not pass through, the catheter was too small, which it should not have been.Customer cannot use this item.

• Brand Name: BARD® POLYURETHANE URETERAL CATHETERS, OPEN TIP
• Common Device Name: URETERAL CATHETER
• 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: 19837728
• Report Number: 1018233-2024-04524
• Device Sequence Number: 20480216
• Product Code: EYB
• UDI-Device Identifier: 10801741126892
• UDI-Public: (01)10801741126892(11)230720(17)260930(10)REHT1353
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 10/30/2024

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: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 134005
• Device Lot Number: REHT1353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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