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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; DRAIN BAG
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C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; DRAIN BAG Back to Search Results
Device Problem Restricted Flow rate (1248)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿bag will not expand/vinyl stuck together¿ with a potential root cause of "static or positive air pressure." the lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.
 
Event Description
It was reported that the drain bag tubing sometimes stalled the urine from passing through.No medical intervention was reported.
 
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Brand Name
URINE COLLECTION
Type of Device
DRAIN BAG
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9249492
MDR Text Key178356099
Report Number1018233-2019-06863
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/29/2019
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 Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/07/2019
Initial Date FDA Received10/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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