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

Catalog Number	120616
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after bladder instillation therapy, writer deflated the balloon and removed 10 mls of sterile water.The cap suddenly detached from the red rubber catheter and unable to unlatched the syringe.Unlatched the syringe after few attempts of removal.Informed the patient what happened, no harm was done.Treatment was finished and patient left unit with no voiced concerns.
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 was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), 2 eye tiemann catheter.Visual inspection of the sample noted the inflation cap/inflation port was disconnected from the inflation arm on the return sample.This does not meet specification per ip7600285, revision 35 which states "missing, damaged, leaking, torn, broken, incomplete or incorrect components are not permitted; the clamp must be closed".Instructions for use were reviewed for this investigation.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, 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 after bladder instillation therapy, writer deflated the balloon and removed 10 mls of sterile water.The cap suddenly detached from the red rubber catheter and unable to unlatched the syringe.Unlatched the syringe after few attempts of removal.Informed the patient what happened, no harm was done.Treatment was finished and patient left unit with no voiced concerns.Per additional information received via email on 19aug2025, it was reported that while deflating balloon, cap fell off catheter tubing.When the troubleshooting was performed, the fluid already removed from balloon.There was no impact/medical intervention to the patient due to the this of the device.
Event or Problem Description
It was reported that after bladder instillation therapy, writer deflated the balloon and removed 10 mls of sterile water.The cap suddenly detached from the red rubber catheter and unable to unlatch the syringe.Unlatched the syringe after few attempts of removal.Informed the patient what happened, no harm was done.Treatment was finished and patient left unit with no voiced concerns.Per additional information received via email on 19aug2025, it was reported that while deflating balloon, cap fell off catheter tubing.When the troubleshooting was performed, the fluid already removed from balloon.There was no impact/medical intervention to the patient due to the this of the device.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), 2 eye tiemann catheter.Visual inspection of the sample noted the inflation cap/inflation port was disconnected from the inflation arm on the return sample.This does not meet specification per ip7600285, revision 35 which states "missing, damaged, leaking, torn, broken, incomplete or incorrect components are not permitted; the clamp must be closed".The labeling is found to be adequate.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 actions can be taken at this time.Corrections: d, g, 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® URETHRAL CATHETER
• Common Device Name: URETHRAL 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: 22458100
• Report Number: 1018233-2025-05682
• Device Sequence Number: 18253570
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974(11)241210(17)281130(10)NGJZ0063
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 10/16/2025

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: Health Professional
• Device Catalogue Number: 120616
• Device Lot Number: NGJZ0063
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 10/16/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 10/08/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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