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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER Back to Search Results
Device Problem Deflation Problem (1149)
Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)
Event Date 01/21/2019
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the balloon on the foley catheter would not deflate.The complainant reported that the nursing staff tried flushing the balloon port, cutting the foley, and attempted to deflate the balloon with a spinal needle but was unsuccessful.The complainant noted that urology was then consulted and urojet was applied.Another attempt was made to deflate the balloon with the spinal needle when the foley slipped out on its own.The balloon and the catheter were reportedly intact.
 
Manufacturer Narrative
The reported event was confirmed manufacturing related since only the manufacturing site had access to the inflation notch.Visual evaluation of the returned sample noted one opened (without original packaging), used cut portion of a silicone foley.It was noted that this was the portion to be inserted into the patient and that the funnel end of the catheter was missing.Functional evaluation could not be performed by inflation and deflation due to sample condition.When the balloon was dissected, it was noted that the inflation notch was not present.Due to how nogales foley catheters are manufactured, the notch was out of specification since it prevented the product from functioning, but the proper specification could not be found due to the product number being unknown.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the urinary drainage product ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that the balloon on the foley catheter would not deflate.The complainant reported that the nursing staff tried flushing the balloon port, cutting the foley, and attempted to deflate the balloon with a spinal needle but was unsuccessful.The complainant noted that urology was then consulted and urojet was applied.Another attempt was made to deflate the balloon with the spinal needle when the foley slipped out on its own.The balloon and the catheter were reportedly intact.
 
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Brand Name
LATEX FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8354121
MDR Text Key136723492
Report Number1018233-2019-00884
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 other,user facility
Type of Report Initial,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2019
Date Manufacturer Received04/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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