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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; URINE DRAINAGE BAG
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C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; URINE DRAINAGE BAG Back to Search Results
Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Material Separation (1562)
Patient Problems Exposure to Body Fluids (1745); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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.
 
Event Description
It was reported that the catheter separated at the uppermost junction before the ezflo valve of the bag as it was being pulled out of the patient.The nurse was allegedly sprayed in the eyes with urine when the disconnect occurred, and subsequently required medical attention.
 
Event Description
It was reported that the catheter separated at the uppermost junction before the ezflo valve of the bag as it was being pulled out of the patient.The nurse was allegedly sprayed in the eyes with urine when the disconnect occurred, and subsequently required medical attention.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product catalog number is unknown, the drainage bag product ifus are found to be adequate based on past reviews.Correction: concomitant medical products and device evaluated by mfr.
 
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Brand Name
URINE COLLECTION
Type of Device
URINE DRAINAGE BAG
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key7574100
MDR Text Key110246436
Report Number1018233-2018-02089
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 company representative,other
Type of Report Initial,Followup
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received06/27/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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