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

Model Number 0165SI14

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); No Flow (2991)

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

Event Date 10/23/2018

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 there was no urine flow from the catheter.Allegedly, when the operator removed the catheter and injected water into it, jelly came out of the catheter.The duration of usage was unknown.Additional information was received via email, on (b)(6) 2018, from (b)(6) (representative).There was flow after jelly came out of the removed catheter.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.The evaluation noted no abnormalities on the returned sample and no foreign material as per the reported event.How and when the event occurred could not be determine.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: "6) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.".

Event Description

It was reported that there was no urine flow from the catheter.Allegedly, when the operator removed the catheter and injected water into it, jelly came out of the catheter.The duration of usage was unknown.Additional information was received via email, on 31 october 2018, from anori ishii (medicon representative).There was flow after jelly came out of the removed catheter.

• Brand Name: BARDEX® I.C. 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: 8081990
• MDR Text Key: 127581336
• Report Number: 1018233-2018-05485
• Device Sequence Number: 0
• Product Code: MJC
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Device Lot Number: 8DK0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1