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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS

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C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS Back to Search Results
Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2018
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 there have been a couple of incidents where a female length catheter from the tray was inserted into a male patient, allegedly due to unclear labelling on the box.The complainant alleged that the outside of the box of the bard tray was not clearly labeled.
 
Event Description
It was reported that there have been a couple of incidents where a female length catheter from the tray was inserted into a male patient, allegedly due to unclear labelling on the box.The complainant alleged that the outside of the box of the bard tray was not clearly labeled.
 
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 catalog number for this product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product catalog number is unknown, this product ifus are found to be adequate based on past reviews.
 
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Brand Name
FOLEY TRAYS
Type of Device
FOLEY TRAY
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7963183
MDR Text Key123803058
Report Number1018233-2018-04744
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 health professional,other
Type of Report Initial,Followup
Report Date 01/21/2019
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 09/20/2018
Initial Date FDA Received10/12/2018
Supplement Dates Manufacturer Received01/04/2019
Supplement Dates FDA Received01/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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