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

Catalog Number 0165L12

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2020

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 during infusion of the catheter balloon, the inflation valve came off the inflation funnel.Per additional information, it has been confirmed that this event occurred during pretest.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.Evaluation found that the valve and cap were disconnected from the inflation funnel of the catheter.There are dents observed on the inflation funnel which indicates that the valve and cap were placed prior to the detachment.The exact cause of how and when the problem occurred could not be determined.However, the potential root cause for this failure mode could be due to improper placement of valve and cap, rough handling by user.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: "1.Method for use: (1) do not inflate the balloon in the urethra.(the urethra may be injured) (2) do not pull the catheter hard.(the bladder/urethra maybe injured) 2.Applicable patients (1) patients with delirium who might pull out catheter (when patient tugs at catheter unconsciously, the bladder and urethra may be damaged).Contraindications 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use on patients who are or have been allergic to natural rubber latex." h11:section a through f - the information provided by bd represents all of 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 during infusion of the catheter balloon, the inflation valve came off the inflation funnel.Per additional information from the ibc via email 18may2020; it has been confirmed that this event occurred during pretest.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10122306
• MDR Text Key: 194618028
• Report Number: 1018233-2020-03583
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Catalogue Number: 0165L12
• Device Lot Number: 9SB003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1