MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER; 2 WAY CATHETER

Catalog Number 0165L18

Device Problems Deflation Problem (1149); Leak/Splash (1354); Contamination /Decontamination Problem (2895)

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

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.

Event Description

It was reported that after placement of the foley on the patient, the foley catheter was found to have a leak and caused the contamination of the foley and urine bag.

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 lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿sterile: unless package has been opened or damaged.Warning: do not use ointments or lubricants having a petroleum base.They will damage latex and may burst balloon.Do not aspirate urine through the drainage funnel wall.Single use only.Do not reserialize.For urological use only.Valve type: use luer slip syringe.Don not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorours aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.".

Event Description

It was reported that after placement of the foley on the patient, the foley catheter was found to have a leak and caused the contamination of the foley and urine bag.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: 2 WAY 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9672732
• MDR Text Key: 182199995
• Report Number: 1018233-2020-00815
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165L18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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