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

Catalog Number 1758SI16

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that upon injecting the sterile water, the water leaked from the inflation valve area of the foley catheter.The representative confirmed a crack under the valve.The inlet tube was cut and the bag was discarded.Per follow up information received via ibc on (b)(6) 2023,the customer confirmed that there was no patient involvement.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Manufacturer Narrative

The reported event is confirmed - manufacturing related.A potential root cause for this failure could be weak or brittle material.Received two (2) photo samples.Both photo samples showcase an overview of 2-way catheter.Received one (1) used 2-way catheter with syringe (without original packaging).Visual inspection noted 0.0825'' tear under inflation valve.This is out of specification which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review is not required because labeling could not have prevented the reported failure.Correction: d,f,h.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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that upon injecting the sterile water, the water leaked from the inflation valve area of the foley catheter.The representative confirmed a crack under the valve.The inlet tube was cut and the bag was discarded.Per follow up information received via ibc on 10oct2023,the customer confirmed that there was no patient involvement.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Type of Device: 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18002465
• MDR Text Key: 326466771
• Report Number: 1018233-2023-07637
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1758SI16
• Device Lot Number: NGGR2940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other