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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; FOLEY CATHETER Back to Search Results
Device Problems Filling Problem (1233); Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the balloon of the catheter was filled with saline instead of sterile water.The ifu stated that the balloon should only be filled with sterile water.The saline crystallized and obstructed the release of fluid from the balloon.A urologist was called in to puncture the balloon.Per follow up with the complainant by email on (b)(6) 2018 the product reference and lot number was unknown and how the balloon of the catheter was deflated was unknown as well.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product family for the all silicone catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the all silicone catheter ifus are found to be adequate based on past reviews.The device was not returned.
 
Event Description
It was reported that the balloon of the catheter was filled with saline instead of sterile water.The ifu stated that the balloon should only be filled with sterile water.The saline crystallized and obstructed the release of fluid from the balloon.A urologist was called in to puncture the balloon.Per follow up with the complainant by email on (b)(6) 2018 the product reference and lot number was unknown and how the balloon of the catheter was deflated was unknown as well.
 
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Brand Name
ALL SILICONE CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7975077
MDR Text Key124344328
Report Number1018233-2018-04842
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 11/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/27/2018
Initial Date FDA Received10/17/2018
Supplement Dates Manufacturer Received11/06/2018
Supplement Dates FDA Received11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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