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

Catalog Number	175808
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the operating room had reported three incidents within a one-week period.No further occurrences have been noted since last wednesday.In two of the incidents, different procedures with separate staff, the balloon ruptured after insertion.In the third incident, as a precaution, the individual tested the balloon prior to insertion, and it would not deflate.They just reported that they encountered another foley issue.Foley was removed and a different foley needed to be inserted.The customer wonders if they pushed the water syringe in far enough to engage the valve in the foley catheter.
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 the operating room had reported three incidents within a one-week period.No further occurrences have been noted since last wednesday.In two of the incidents, through different procedures with separate staff, the balloon ruptured after insertion.In the third incident, as a precaution, the individual tested the balloon prior to insertion, and it would not deflate.They just reported that they encountered another foley issue.Foley was removed and a different foley needed to be inserted.The customer wonders if they pushed the water syringe in far enough to engage the valve in the foley catheter.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.The instructions for use were found adequate and state the following: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.4.If the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.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.

• Brand Name: BARDEX® LUBRI-SIL® 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 30014 ; 7707846100
• MDR Report Key: 20999833
• Report Number: 1018233-2024-08184
• Device Sequence Number: 17847111
• Product Code: EZL
• UDI-Device Identifier: 00801741034275
• UDI-Public: (01)00801741034275
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K984084
• 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): 01/08/2025

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: 175808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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