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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; UNKNOWN CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 LATEX FOLEY CATHETER; UNKNOWN CATHETER Back to Search Results
Device Problems Misassembled (1398); Positioning Problem (3009)
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 customer noticed when they pulled the magic 3 catheter package out of the box, the gripping sleeve and water were not properly placed in the bag.The catheter was upside down.They stated that it made it difficult to get the gripping sleeve to the top and it caused an inconvenience.They stated they would prefer if the gripping sleeve was onto the exit port.
 
Event Description
It was reported that the customer noticed when they pulled the magic 3 catheter package out of the box, the gripping sleeve and water were not properly placed in the bag.The catheter was upside down.They stated that it made it difficult to get the gripping sleeve to the top and it caused an inconvenience.They stated they would prefer if the gripping sleeve was onto the exit port.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product code is unknown, the intermittent catheter labeling is found to be adequate based on past reviews.Correction: initial reporter name and address.
 
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Brand Name
LATEX FOLEY CATHETER
Type of Device
UNKNOWN CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9286930
MDR Text Key179429756
Report Number1018233-2019-07107
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 consumer,other
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received11/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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