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

Catalog Number	175816
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
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 foley catheter balloon would not inflate or deflate appropriately.Upon insertion of foley urine was returned, balloon was then attempted to be inflated, balloon only accepted 4 cc of fluid before it would not inflate any further.Attempt then made to retract fluid from balloon and it would not come back out.We were able to manipulate the balloon repeatedly until most the fluid was removed from the balloon so we could then remove the catheter.Catheter placed in red biohazard bag and given to clinical manager.
Event or Problem Description
It was reported that foley catheter balloon would not inflate or deflate appropriately.Upon insertion of foley urine was returned, balloon was then attempted to be inflated, balloon only accepted 4 cc of fluid before it would not inflate any further.Attempt then made to retract fluid from balloon and it would not come back out.We were able to manipulate the balloon repeatedly until most the fluid was removed from the balloon so we could then remove the catheter.Catheter placed in red biohazard bag and given to clinical manager.
Additional Manufacturer Narrative
The reported event is unconfirmed.Visual evaluation noted received 1 all-silicone foley catheter with sample port connector.Using in house syringe the catheter was inflated with 10 ml methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water).Encountered resistance but was able to inflate balloon properly.Deflated balloon within 4 mins 41 mins using in house syringe.No root cause could be found because the reported event was unconfirmed.The dhr review is not required as the reported event is unconfirmed.Labelling review is not required as the reported event is unconfirmed.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: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21208988
• Report Number: 1018233-2025-00238
• Device Sequence Number: 8070861
• Product Code: EZL
• UDI-Device Identifier: 00801741074110
• UDI-Public: (01)00801741074110(11)240925(17)290917(10)NGJW1294
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 175816
• Device Lot Number: NGJW1294
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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