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

Catalog Number 129416M

Device Problem No Flow (2991)

Patient Problem 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.The information provided by bard 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 bard.

Event Description

It was reported that urine would not flow through the catheter.

Manufacturer Narrative

Received 1 used catheter with drainage bag.The reported event was confirmed as use related.The exterior of the device was visually inspected and encrustation was found in the drainage eye and on the balloon.Per functional testing, the balloon was inflated with 10cc of water and found that no water flowed through the drain lumen.The process was repeated with the balloon deflated and found that no water flowed through the drainage lumen.Per testing, the device did not meet the minimum flow rate requirements of 150cc/min.The catheter was dissected and found that encrusted matter packed the inside of the drain lumen and obstructed the flow of the water.This is a patient related condition with use that is dependent on many variables, such as diet and medication.However, this is not a manufacturing related condition.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed." (b)(4).

Event Description

It was reported that urine would not flow through the catheter.

• Brand Name: BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6572597
• MDR Text Key: 75438452
• Report Number: 1018233-2017-02442
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

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 Expiration Date: 08/31/2021
• Device Catalogue Number: 129416M
• Device Lot Number: LR6228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 08/24/2017
• Supplement Dates FDA Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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