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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE
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C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAINAGE Back to Search Results
Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Blocked Connection (2888)
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 wound drain tubing clogged and began to leak.The user allegedly experienced difficulty measuring the drainage.
 
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 wound drainage product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the wound drainage product ifus are found to be adequate based on past reviews.
 
Event Description
It was reported that the wound drain tubing clogged and began to leak.The user allegedly experienced difficulty measuring the drainage.
 
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Brand Name
WOUND DRAINAGE
Type of Device
WOUND DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8053227
MDR Text Key128390131
Report Number1018233-2018-05281
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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