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

Catalog Number	900114A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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.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 during the pretest, the foley catheter balloon swelled to one side at the ratio of 10:0.So, they discontinued the use.Per investigator's notification received on 15jan2025, it was reported that difficult to deflate found during sample evaluation associated to the syringe.
Additional Manufacturer Narrative
The reported event was confirmed and an additional record has been created to investigate the difficulty to deflate the balloon associated to the returned syringe.Visual: received 1 all silicone foley catheter with syringe.Visually inspected the catheter and no physical defects were present.Inflated the balloon with the returned syringe and 10 ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and it inflated properly, however the balloon concentricity was asymmetrical 90:10 as compared to attachment 1 of tm0300903, rev 3.Attempted to deflate the balloon using the returned syringe but it did not deflate passively in under 5 minutes.Inflated and deflated the balloon with inhouse syringe and it deflated passively in under 5 minutes: 3 minutes and 3 seconds.He returned sample does not meet specification as per inspection procedure ip7603444 revision 0 which states: "balloon testing for symmetry must not exceed a ratio of 70:30 when measured from the side of the shaft." the difficulty to deflate noted is cascading from the asymmetrical balloon.The labeling is 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, e, 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.
Event or Problem Description
It was reported that during the pretest, the foley catheter balloon swelled to one side at the ratio of 10:0.So, they discontinued the use.Per investigator's notification received on 15jan2025, it was reported that difficult to deflate found during sample evaluation associated to the syringe.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY
• Common Device Name: SILICONE 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: 21292317
• Report Number: 1018233-2025-00496
• Device Sequence Number: 15390146
• Product Code: MJC
• UDI-Device Identifier: 00801741032929
• UDI-Public: (01)00801741032929(11)240325(17)270228(10)MYJP2033
• 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): 10/13/2025

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 Catalogue Number: 900114A
• Device Lot Number: MYJP2033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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