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

Model Number 0165SI16

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 07/19/2017

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 as the user infused the water into the balloon, inflation occurred around the inflation valve of the catheter instead of the balloon.This occurred during a pretest and another device was later used.

Event Description

It was reported that as the user infused the water into the balloon, inflation occurred around the inflation valve of the catheter instead of the balloon.This occurred during a pretest and another device was later used.

Manufacturer Narrative

The reported event was confirmed.Received only the catheter for evaluation.The catheter was visually evaluated and it was observed that the inflation lumen was pinched and there was an external dent mark at the location of the pinch.The lumen appeared to have been clamped off.The following functional test was performed: tested using lab syringe, unable to inflate the balloon with 10ml.Instead, the inflation funnel filled with water and ballooned out.Deflated and repeated using quick fill technique and achieved the same result.Manipulate the pinched lumen on the shaft using finger and after few second, no pinch observed.Re-inflated and deflated the balloon with 10ml water and the balloon inflated and deflated without difficulty.Per the dimensional evaluation, the following results were found: pinched inflation lumen 13cm from tip eye snip length 3/32" eye snip width 2/32" eye snip distance from distal cuff 6/32" eye snip distance from proximal cuff 4/32" rubberize thickness 9 thou reinforcement 155 thou inflation funnel thickness 50 thou balloon thickness (average) 25 thou inflation lumen coverage 10thou the evaluation verified that the pinched lumen was the cause of the balloon being difficult to inflate.The pinch was not permanent and can be released.This condition was a result of post manufacturing damage and was not manufacturing related.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: " [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use in patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter." (b)(4).

• 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; lot 57c; covington GA 30014
• MDR Report Key: 6797215
• MDR Text Key: 83000180
• Report Number: 1018233-2017-04252
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016752
• UDI-Public: (01)00801741016752
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: 0165SI16
• Device Catalogue Number: 0165SI16
• Device Lot Number: 7AL9115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Date Manufacturer Received: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1