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

Catalog Number 175816

Device Problems Burst Container or Vessel (1074); Material Puncture/Hole (1504)

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

Event Date 12/12/2023

Event Type  malfunction  

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.

Event Description

It was reported that indwelling foley catheter was inserted.When inflating balloon with the prefilled syringe, the balloon burst and slid out of patient.

Manufacturer Narrative

The reported event is confirmed as manufacturing related.The root cause identified was difficult to assure the positioning of the catheter due to vision was difficult.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required.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 Description

It was reported that indwelling foley catheter was inserted.When inflating balloon with the prefilled syringe, the balloon burst and slid out of patient.

• Brand Name: BARDEX® LUBRI-SIL® 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: 18595487
• MDR Text Key: 333966184
• Report Number: 1018233-2024-00286
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 175816
• Device Lot Number: NGHX0545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2023
• 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
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 64 KG