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

Catalog Number	1758SI12
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name:(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 the foley catheter use was discontinued because there was a white residue near the tamper-evident seal.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received (6) photo samples.Visual evaluation of the photo samples notes one opened (without original packaging), used silicone foley catheter.Verified material number 2758j12 and manufacturing lot number ngjw0148 and batch number mykr3307.The third and fourth photo provides an enlarged view of the catheter inlet tube sample port, confirming the foreign material.Received 1 all silicone foley catheter with sample connector and packaging label.Verified material number 2758j12 and manufacturing lot number ngjw0148 and batch number mykr3307.Visual inspection noted foreign material on inlet tube above the sample port.This does not meet specification which states " product or assembly must be free from visible loose or embedded foreign matter larger than an aggregate total of 0.6mm or 1 of 16 in length per tappi dirt estimation chart (maximum 3 particles per side or surface)." root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be" environmental, alcohol, operation error".However, there was insufficient information to confirm this potential root cause.A labeling review was not performed because labeling 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.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d, f, h.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 the foley catheter use was discontinued because there was a white residue near the tamper evident seal.

• 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: 23728000
• Report Number: 1018233-2025-10819
• Device Sequence Number: 13319921
• Product Code: MJC
• UDI-Device Identifier: 00801741025204
• UDI-Public: (01)00801741025204(11)240918(17)290910(10)NGJW0148
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K984136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 1758SI12
• Device Lot Number: NGJW0148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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