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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT Back to Search Results
Catalog Number 0165L18
Device Problems Deflation Problem (1149); Difficult to Remove (1528); 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 allegedly found that the inflation funnel had torn off and the user tried to remove the catheter, but was unsuccessful.The nurse then cut the inflation funnel off with scissors.The catheter was then pulled, but was still unable to be removed.After a few hours, it was confirmed by abdominal ultrasound that the balloon was deflated.The user then pulled the catheter again, and it was finally removed.As a result, the catheter was replaced with another catheter.There was no patient injury reported.
 
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 allegedly found that the inflation funnel had torn off and the user tried to remove the catheter, but was unsuccessful.The nurse then cut the inflation funnel off with scissors.The catheter was then pulled, but was still unable to be removed.After a few hours, it was confirmed by abdominal ultrasound that the balloon was deflated.The user then pulled the catheter again, and it was finally removed.As a result, the catheter was replaced with another catheter.There was no patient injury reported.
 
Manufacturer Narrative
The reported issue was inconclusive.The catheter was received cut into 2 pieces.The sample was evaluated and no pinch or blockage was observed.Able to introduce water into the returned catheter, however no conditions were found on the sample that could be associated with the reported event.Due to 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 state 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 allegedly found that the inflation funnel had torn off and the user tried to remove the catheter, but was unsuccessful.The nurse then cut the inflation funnel off with scissors.The catheter was then pulled, but was still unable to be removed.After a few hours, it was confirmed by abdominal ultrasound that the balloon was deflated.The user then pulled the catheter again, and it was finally removed.As a result, the catheter was replaced with another catheter.There was no patient injury reported.
 
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Brand Name
BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER, TWO OPPOSED EYES, SHORT
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
lot 57c
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
lot 57c
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6280976
MDR Text Key66061705
Report Number1018233-2017-00204
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,Followup
Report Date 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
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 Received09/13/2017
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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