MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE

Catalog Number	0102L14
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
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.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 the hospital user inserted catheter and inflated balloon with 10 mls sterile water.After a few minutes of letting the bladder drain, hospital user noticed that the green tip where sterile water was instilled had fallen off and the sterile water drained out.Hospital user called coworker to look at catheter and to bring another catheter to reinsert.Fortunately, patient tolerated well.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.The labeling is found to be adequate.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.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 the hospital user inserted catheter and inflated balloon with 10 mls sterile water.After a few minutes of letting the bladder drain, hospital user noticed that the green tip where sterile water was instilled had fallen off and the sterile water drained out.Hospital user called coworker to look at catheter and to bring another catheter to reinsert.Fortunately, patient tolerated well.
Event or Problem Description
It was reported that the hospital user inserted catheter and inflated balloon with 10 mls sterile water.After a few minutes of letting the bladder drain, hospital user noticed that the green tip where sterile water was instilled had fallen off and the sterile water drained out.Hospital user called coworker to look at catheter and to bring another catheter to reinsert.Fortunately, patient tolerated well.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.The labeling is found to be adequate, and it states, instructions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Insertion: 7.Inflate the balloon with pre-filled water syringe if included.A.If pre-filled syringe is not included, then use a slip tip/luer lock syringe to fill catheter balloon with sterile water.Do not use needle.B.Do not exceed recommended capacities as stated on the applicable labeling of the catheter.C.The chart below provides additional information on inflation volume and balloon size.D.Inflation volume incorporates the volume required to pass through lumen and fully inflate the specific balloon size.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: e, 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: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Common Device Name: FOLEY 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: 22467902
• Report Number: 1018233-2025-05705
• Device Sequence Number: 19857760
• Product Code: EZC
• UDI-Device Identifier: 00801741018114
• UDI-Public: (01)00801741018114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• 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: 0102L14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 10/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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