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

Catalog Number 175808

Device Problems Partial Blockage (1065); No Flow (2991)

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 foleys were blocked and did not drain or flush.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter.Visual inspection of the sample noted significant tape around catheter.The tape was removed and the drainage lumen was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) with no leakage or other issues noted.The solution flowed freely and without impediment through the drainage lumen and out of the catheter.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).The balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated without issue, returning 10ml of solution.No cuffing was noted.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.To deflate catheter balloon: gently insert a luer slip tip 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.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol." 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 the foleys were blocked and did not drain or flush.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9853619
• MDR Text Key: 186333954
• Report Number: 1018233-2020-01943
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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: 175808
• Device Lot Number: NGDU0372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 04/20/2020
• Supplement Dates FDA Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1