MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 BARDEX I. C. 3-WAY TEMPERATURE-SENSING FOLEY CATHETER 10CC WITHOUT PRE-ATTACHED

Catalog Number 129614

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2017

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 the catheter failed to infuse water into the balloon during the pretest.

Manufacturer Narrative

Received only 3 way tsc catheter.The exterior of the sample was inspected and no evidence of a failure was found that would support the reported event.Per the functional testing, the balloon was inflated, using a lab syringe, with 10 cc water using normal fill technique and the balloon inflated without difficulty in 6 sec.The inflation funnel did not balloon out during inflation.The balloon was deflated and re-inflated again with quick fill technique and the balloon inflated without difficulty and the inflation funnel did not balloon out during inflation.The sample was dissected and did not find anything to contribute to the reported problem.The dimensional evaluation results were as follows: eye snip length: 3/32¿, eye snip width: 1/32¿, eye snip distance from distal cuff: 9/32¿, eye snip distance from proximal cuff: 6/32¿, rubberize thickness: 6 thou, reinforcement: 159 thou, inflation funnel thickness: 58 thou, balloon thickness (average): 23 thou, inflation lumen coverage: 8 thou.The reported event could not be confirmed as the problem could not be reproduced.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: "to inflate and deflate the balloon use a luer tip careless syringe".(b)(4).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 the catheter failed to infuse water into the balloon during the pretest.

• Brand Name: BARDEX I. C. 3-WAY TEMPERATURE-SENSING FOLEY CATHETER 10CC WITHOUT PRE-ATTACHED
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer (Section G): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6313836
• MDR Text Key: 67286256
• Report Number: 1018233-2017-00379
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 129614
• Device Lot Number: 6EN7056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2016
• 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