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

Catalog Number	73018SI
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
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, customer observed leakage at the junction of the foley catheter draining site.This appear to be a product defect.This event happened in operation theatre.Last event incident happened the same leakage issue which was reported on 09aug2025 in medical icu.This incident was second time in this hospital.Catheter was discarded once user find leakage on the catheter.
Additional Manufacturer Narrative
The reported event is inconclusive.Received (1) photo sample.Visual inspection of the photo sample noted one packaging label for a 3-way all-silicone foley catheter.Verified material 73018si, and lot number ngjz0367.The condition of the affected catheter could not be confirmed because only a photo was provided for the investigation.Functional testing was not possible based solely on the photo.Therefore, the reported event is considered inconclusive due to the inadequate sample condition.A labeling review was not performed because labelling could not have prevented the reported failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction made to tab 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, customer observed leakage at the junction of the foley catheter draining site.This appear to be a product defect.This event happened in operation theatre.Last event incident happened the same leakage issue which was reported on (b)(6) 2025 in medical icu.This incident was second time in this hospital.Catheter was discarded once user find leakage on the catheter.

• 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: 23167317
• Report Number: 1018233-2025-08663
• Device Sequence Number: 9612115
• Product Code: MJC
• UDI-Device Identifier: 00801741025495
• UDI-Public: (01)00801741025495(11)250107(17)291029(10)NGJZ0367
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 73018SI
• Device Lot Number: NGJZ0367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• 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