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

Catalog Number	010112
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient arrived for their bcg treatment was prepped and used bard #12 french urological catheter tiemann model coude tip was inserted into bladder was drained, bcg place the hub of the catheter and began to infuse, pin hole noted at the hub of the intermittent catheter.Immediately stopped treatment.Second catheter opened noted pin hole, not used.Opened bard #14 coude tip no pin hole noted.Under sterile technique catheter inserted and treatment given.
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.
Event or Problem Description
It was reported that patient arrived for their bcg treatment was prepped and used bard #12 french urological catheter tiemann model coude tip was inserted into bladder was drained, bcg place the hub of the catheter and began to infuse, pin hole noted at the hub of the intermittent catheter.Immediately stopped treatment.Second catheter opened noted pin hole, not used.Opened bard #14 coude tip no pin hole noted.Under sterile technique catheter inserted and treatment given.Per additional information received on 01aug2025, it was reported that source of leak identified, product changed out.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted six unopened (with original packaging), urological catheters.Visual inspection of the six-sample noted that using the (in-house) syringe the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and inflated properly with no leakage.With the syringe (in-house) syringe attached the balloon deflated passively with no leakage.Flushed all six catheters drainage lumen with water and no pinhole observed that would cause leakage.The reported failure could not be replicated.No root cause could be found because the reported event was unconfirmed.As the reported event is unconfirmed, a risk review is not required.As the reported event is unconfirmed, a labeling review is not required.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.Corrections: b, d, e, h udi format updated with available product information per gudid.H11: sections 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® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: INTERMITTENT 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, GA 30014 ; 7707846100
• MDR Report Key: 22293187
• Report Number: 1018233-2025-04751
• Device Sequence Number: 18208614
• Product Code: KOD
• UDI-Device Identifier: 00801741029851
• UDI-Public: (01)00801741029851(11)240709(17)280930(10)NGJT0049
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 10/23/2025

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: 010112
• Device Lot Number: NGJT0049
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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 Sex: Unknown