MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETER; INTERMITTENT CATHETER

Model Number	120616
Medical Device Problem Codes	Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tiemann catheter had a funk or unidentifiable substance inside of it.
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 tiemann catheter had a funk or unidentifiable substance inside of it.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Photo samples for an orange coude catheter were returned.The catheter eye was noted to have scorching marks from the hand burning process.As the reported failure was caused by manufacturing error the product is considered to not meet specifications.The product was not used on a a patient but is intended for treatment purposes.A potential root cause for this failure mode could be, "operator error".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation no additional action is required at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event was confirmed manufacturing related.Correction: f,g,h h11:section a through f - the information provided by bd represents all of 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.The actual/suspected device was inspected.

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: INTERMITTENT 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13753596
• Report Number: 1018233-2022-01263
• Device Sequence Number: 17334035
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/08/2022

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: 02/28/2025
• Device Model Number: 120616
• Device Catalogue Number: 120616
• Device Lot Number: NGEZ2235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 03/13/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2021
• 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