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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; NIGHT BAG FOR BAG STAND FS3
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C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; NIGHT BAG FOR BAG STAND FS3 Back to Search Results
Device Problems Loss of or Failure to Bond (1068); Deformation Due to Compressive Stress (2889); Connection Problem (2900); Detachment of Device or Device Component (2907)
Patient Problem Discomfort (2330)
Event Date 10/01/2018
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 bag stand would not hold the drainage bag in a position that keeps the tube in correct position to drain properly.The bag does not connect to the stand in a way that keeps the drainage tube from kinking and draining properly.The patient experienced some discomfort and has to rearrange themselves often during the night.
 
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 urine collection product ifus are found to be adequate based on past reviews.The device was not returned.
 
Event Description
It was reported that the bag stand would not hold the drainage bag in a position that keeps the tube in correct position to drain properly.The bag does not connect to the stand in a way that keeps the drainage tube from kinking and draining properly.The patient experienced some discomfort and has to rearrange themselves often during the night.
 
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Brand Name
URINE COLLECTION
Type of Device
NIGHT BAG FOR BAG STAND FS3
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7999297
MDR Text Key124972009
Report Number1018233-2018-04922
Device Sequence Number1
Product Code KNX
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2018
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 Received11/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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