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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
Catalog Number UNKNOWN
Device Problems Restricted Flow rate (1248); Therapeutic or Diagnostic Output Failure (3023)
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 stopped draining.The device was reportedly replaced.
 
Event Description
It was reported that the wound drain stopped draining.The device was reportedly replaced.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the wound drainage product ifus are found to be adequate based on past reviews.Section a through f - the information provided by bd 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 bd.
 
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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 Key8359758
MDR Text Key137125731
Report Number1018233-2019-00967
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 health professional,other,use
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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