MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; COUDE CATHETER

Catalog Number	010114
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer was still trying to get pictures of the ureteral catheters that the think accurately demonstrates the variation.It was much more noticeable in person.Per sample form received on 20dec2024, it was reported that the patient was getting the 802514 catheters that were great product no complaints.But then patient was started getting a different catheter with a much thinner and pointer, sharper tip that was made in malaysia.It was made from different rubber and poor quality.This one used the same numbers as the good ones, but seemed like knock off counter it.But the main problem was the malaysia one was pointy.The bad ones were the malaysia ones with 010114 being the worst and also included a good one for comparison which was mexico.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Additional Manufacturer Narrative
The reported event is unconfirmed.Visual evaluation noted received 2 unopened urethral catheters and 1 unopened urological catheter.No root cause could be found because the reported event was unconfirmed.Dhr review is not required as the reported event is unconfirmed however dhr review was completed after the sample evaluation.Labelling review is not required as the reported event is unconfirmed.Correction: d, e, h.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 was still trying to get pictures of the ureteral catheters that the think accurately demonstrates the variation.It was much more noticeable in person.Per sample form received on 20dec2024, it was reported that the patient was getting the 802514 catheters that were great product no complaints.But then patient was started getting a different catheter with a much thinner and pointer, sharper tip that was made in malaysia.It was made from different rubber and poor quality.This one used the same numbers as the good ones, but seemed like knock off counter it.But the main problem was the malaysia one was pointy.The bad ones were the malaysia ones with 010114 being the worst and also included a good one for comparison which was mexico.Patient experienced discomfort and mild pain.No medical intervention was reported.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21101135
• Report Number: 1018233-2024-08631
• Device Sequence Number: 18309057
• Product Code: KOD
• UDI-Device Identifier: 00801741029868
• UDI-Public: (01)00801741029868(11)240119(17)280531(10)NGHZ2029
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/26/2025

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 Catalogue Number: 010114
• Device Lot Number: NGHZ2029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Weight: 82 KG