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

Catalog Number 129414M

Device Problems Deflation Problem (1149); Inaccurate Flow Rate (1249); Material Twisted/Bent (2981); No Flow (2991)

Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

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 was no urine flow observed.This continued for 1 hour, then the user tried to remove the catheter for replacement, and found the balloon was difficult to deflate.An echo and ct scan were done and confirmed that the balloon part of the catheter was bent and placed.The user then cut the inflation lumen but no water would come out.A guidewire was inserted in to the inflation lumen, the balloon then deflated and the catheter was removed.Per additional information received via email on 9 december 2019 from ibc representative, the guidewire was used to deflate the balloon.There were no missing pieces of the balloon.

Manufacturer Narrative

The reported event was inconclusive due to the condition of the sample.A potential root cause for this failure mode could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).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: "[intended use & effect-efficacy] the device is a tray kit product that is used for the purpose of urinary drainage and measurement of core body temperature.It combines a balloon catheter with temperature-sensing designed to be placed in the bladder, and a urinary drainage bag." 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 was no urine flow observed.This continued for 1 hour, then the user tried to remove the catheter for replacement, and found the balloon was difficult to deflate.An echo and ct scan were done and confirmed that the balloon part of the catheter was bent and placed.The user then cut the inflation lumen but no water would come out.A guidewire was inserted in to the inflation lumen, the balloon then deflated and the catheter was removed.Per additional information received via email on 9 december 2019 from ibc representative, the guidewire was used to deflate the balloon.There were no missing pieces of the balloon.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING 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: 9491837
• MDR Text Key: 178621483
• Report Number: 1018233-2019-08077
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 129414M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1