MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® LUBRICATH® FOLEY CATHETER; HYDROGEL FOLEY CATHETER

Model Number 365718

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the balloon prematurely deflated and as a result fell out of the patient.This resulted in multiple catheter changes.

Event Description

It was reported that the balloon prematurely deflated and as a result fell out of the patient.This resulted in multiple catheter changes.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure mode could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use.".

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Type of Device: HYDROGEL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8542094
• MDR Text Key: 142906577
• Report Number: 1018233-2019-02139
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741077753
• UDI-Public: (01)00801741077753
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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: Lay User/Patient
• Device Expiration Date: 01/01/2023
• Device Model Number: 365718
• Device Catalogue Number: 365718
• Device Lot Number: 8AT8084
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1