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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMRIX PHARMACEUTICALS, LTD./ETHICON, INC. EVICEL FIBRIN SEALANT KIT; SYRINGE, PISTON
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OMRIX PHARMACEUTICALS, LTD./ETHICON, INC. EVICEL FIBRIN SEALANT KIT; SYRINGE, PISTON Back to Search Results
Lot Number 15-0044
Device Problems Air Leak (1008); Break (1069)
Patient Problem No Information (3190)
Event Date 07/22/2015
Event Type  malfunction  
Event Description
Evicel was given to the scrub tech by the circulating rn by placing it into the vial cups.The scrub tech then attached the vial cups containing the vials of medication to the vial connectors.However, the vial connector containing the thrombin broke off before she could draw the medication up into the syringes.Thrombin was then drawn up using sterile technique and placed into the syringe.When this was done only 2mls of medication was drawn into each syringe instead of the 5ml dose.The medication also appeared very foamy at first and then a formed substance.The medication was then passed off the field as it was unusable and a new evicel was obtained and used for the procedure.It was verified that the thrombin vials were supposed to be 5mls.
 
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Brand Name
EVICEL FIBRIN SEALANT KIT
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
OMRIX PHARMACEUTICALS, LTD./ETHICON, INC.
c/o raina dauria, route 22 west
somerville NJ 08876
MDR Report Key5052863
MDR Text Key24906509
Report Number5052863
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 08/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date04/01/2018
Device Lot Number15-0044
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/06/2015
Event Location Hospital
Date Report to Manufacturer08/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
N/A-INCIDENT HAPPENED BEFORE REACHING THE PATIENT.
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