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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD SDN. BHD. -8040607 BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH,
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BARD SDN. BHD. -8040607 BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH, Back to Search Results
Catalog Number 0165L18
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2016
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 inflation funnel of the catheter was torn.The catheter was inserted into the patient on (b)(6) 2016.On (b)(6) 2016, it was found that the funnel had torn off.The user allegedly tried to remove the catheter, but it was unsuccessful.It was later reported that the device was with scissors by the nurse, after which, the catheter was pulled by hand; however, was unable to be removed.After a few hours, it was reported that the balloon was deflated by abdominal ultrasound.Subsequently, the user pulled the catheter and was able to successfully remove the device.The device was replaced, and no patient injury was reported.
 
Manufacturer Narrative
Received only catheter cut into 2 pieces, first piece - 6.5cm and second piece - 44cm.Per visual evaluation a tear was noted on the inflation funnel.The tear was examined under a microscope and noted to be long and smooth.The tear appeared to be caused by a sharp object from the outside.However, due to the poor condition of the returned sample, a complete evaluation could not be performed.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments".(b)(4).
 
Event Description
It was reported that the inflation funnel of the catheter was torn.The catheter was inserted into the patient on (b)(6) 2016.On (b)(6) 2016, it was found that the funnel had torn off.The user allegedly tried to remove the catheter, but it was unsuccessful.It was later reported that the device was with scissors by the nurse, after which, the catheter was pulled by hand; however, was unable to be removed.After a few hours, it was reported that the balloon was deflated by abdominal ultrasound.Subsequently, the user pulled the catheter and was able to successfully remove the device.The device was replaced, and no patient injury was reported.
 
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Brand Name
BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT LENGTH,
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 Key6312275
MDR Text Key67237358
Report Number1018233-2017-00352
Device Sequence Number1
Product Code EZC
Combination Product (y/n)N
PMA/PMN Number
K910846
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 08/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0165L18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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