MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER

Catalog Number	0170SI14
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
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 foley catheter balloon was not holding the instillation of the sterile water.The foleys inadvertently came out of the patient.The second time around, the cnl tested the balloon and noted it leaking.This happened twice for this patient - requiring the patient to receive a total of 3 foleys.They had the defective product and to send back.It was noted that the given lot# nghy3201.
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 foley catheter balloon was not holding the instillation of the sterile water.The foleys inadvertently came out of the patient.The second time around, the cnl tested the balloon and noted it leaking.This happened twice for this patient - requiring the patient to receive a total of 3 foleys.They had the defective product and to send back.It was noted that the given lot# was nghy3201.
Event or Problem Description
It was reported that the foley catheter balloon was not holding the instillation of the sterile water.The foleys inadvertently came out of the patient.The second time around, the cnl tested the balloon and noted it leaking.This happened twice for this patient - requiring the patient to receive a total of 3 foleys.They had the defective product and to send back.It was noted that the given lot# was nghy3201.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used lubri-sil all silicone foley catheter.Visual inspection of the sample noted 1 two-way foley catheter with balloon rupture (measuring 0.4730").The labeling was reviewed and 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.Correction: d, f, 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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• 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: 21935214
• Report Number: 1018233-2025-03130
• Device Sequence Number: 15449896
• Product Code: MJC
• UDI-Device Identifier: 00801741104374
• UDI-Public: (01)00801741104374(11)240111(17)260131(10)NGHY3201
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K984136
• 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): 08/07/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 0170SI14
• Device Lot Number: NGHY3201
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 08/07/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 06/06/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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