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

Catalog Number	175812
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone number provided (b)(6).The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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 they had received another complaint from their department regarding a catheter in a 12ch lubrisil foley tray and there had been a further issue with a foley catheter today during the elective caesarean section it fell out post lot ngku2949 first issue in a while so they did not want to remove the whole stock as it could be a one off.
Event or Problem Description
It was reported that they had received another complaint from their department regarding a catheter in a 12ch lubrisil foley tray and there had been a further issue with a foley catheter today during the elective caesarean section it fell out post lot ngku2949 first issue in a while so they did not want to remove the whole stock as it could be a one off.Per notification from investigator on 05jan2026 it was reported that the failure balloon cuffing was found was found during sample evaluation on 09dec2025.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The initial reporter's facility name: chesterfield royal hospital nhs foundation trust.The reported event was unconfirmed.The labeling is found to be adequate.Dhr review is not required as the reported event is unconfirmed; however, dhr was previously performed.Based on the results of the investigation no additional actions are required at this time.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Event or Problem Description
It was reported that they had received another complaint from their department regarding a catheter in a 12ch lubrisil foley tray and there had been a further issue with a foley catheter today during the elective caesarean section it fell out post lot ngku2949 first issue in a while so they did not want to remove the whole stock as it could be a one off.Per notification from investigator on 05jan2026 it was reported that the failure balloon cuffing was found was found during sample evaluation on 09dec2025.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received 1 unopened foley catheterization tray.Verified material number tr17582l12 and batch number ngku2949.Visual inspection noted no obvious observations catheter filled with 10ml mbs using returned syringe.Inflated with no difficulty.No leakage present.Risk, labelling, and dhr reviews are not required as the reported event is unconfirmed.Correction: b, d, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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® 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: 23490104
• Report Number: 1018233-2025-10013
• Device Sequence Number: 8672440
• Product Code: EZL
• UDI-Device Identifier: 10888439517255
• UDI-Public: (01)10888439517255(11)250831(17)271210(10)NGKU2949
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K984084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 175812
• Device Lot Number: NGKU2949
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 01/08/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/09/2026; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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