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

Catalog Number	1758SI14
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was difficulty in draining sterilized water from the foley catheter during pre-test.
Additional Manufacturer Narrative
The complete initial reporter's facility name that was provided was (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: 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.
Additional Manufacturer Narrative
The reported event was unconfirmed.Four photos were received for evaluation of the silicone foley catheter with syringe.The photos showed that the balloon was inflated.However, unable to confirm reported event based on these photos.Received 1 all silicone foley catheter with syringe.Verified material number 2758j14 and manufacturing lot number ngjz2837.Visual inspection noted the catheter balloon was asymmetrical.Catheter was filled with 10 ml of methylene blue solution (3 drops 1 percent methylene blue per 100 ml distilled water) using the returned syringe.Catheter was able to inflate and rest without issues.The balloon was able to passively deflate within one minute without issue.The reported event was unconfirmed.Risk review is not required as the reported event was unconfirmed.Labelling revied is not required as the reported event was unconfirmed.Dhr is not required as the reported event was unconfirmed.No additional actions can be taken at this time.Corrections: d, e, 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 there was difficulty in draining sterilized water from the foley catheter during pre test.Per notification from investigator on 16feb2026, it was reported that asymmetrical balloon was found with 75 25 concentricity and after deflation mushrooming present during sample evaluation on 24dec2025.

• 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: 23073649
• Report Number: 1018233-2025-08236
• Device Sequence Number: 4645189
• Product Code: MJC
• UDI-Device Identifier: 10801741052795
• UDI-Public: (01)10801741052795(11)250114(17)300113(10)NGJZ2837
• 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): 03/19/2026

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: 1758SI14
• Device Lot Number: NGJZ2837
• 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: 09/11/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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