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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; SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; SILICONE FOLEY CATHETER Back to Search Results
Device Problems Folded (2630); Mushroomed (2987)
Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
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.The device was not returned.
 
Event Description
It was reported that the balloon of the latex-free foley catheter "appears to be partial folded over the tip" and got stuck in the urethra of a patient.It was reported that "urology was called and they were able to remove without trauma.".
 
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 this silicone catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that the balloon of the latex-free foley catheter "appears to be partial folded over the tip" and got stuck in the urethra of a patient.It was reported that "urology was called and they were able to remove without trauma.".
 
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Brand Name
ALL SILICONE CATHETER
Type of Device
SILICONE FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7378511
MDR Text Key103925742
Report Number1018233-2018-00986
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 company representative,other
Type of Report Initial,Followup
Report Date 04/10/2018
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 03/07/2018
Initial Date FDA Received03/28/2018
Supplement Dates Manufacturer Received04/06/2018
Supplement Dates FDA Received04/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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