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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREINER BIO-ONE VACUETTE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
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GREINER BIO-ONE VACUETTE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION Back to Search Results
Catalog Number 450225
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2019
Event Type  malfunction  
Event Description
Two different occasions, while transferring blood from a 10cc syringe after a central line draw, the vacuette blood transfer unit failed.On both occasions the needle remained in the tube, first was a lavender tube and the second was a mint tube.
 
Event Description
Two different occasions, while transferring blood from a 10cc syringe after a central line draw, the vacuette blood transfer unit failed.On both occasions the needle remained in the tube, first was a lavender tube and the second was a mint tube.
 
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Brand Name
VACUETTE
Type of Device
TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Manufacturer (Section D)
GREINER BIO-ONE
4238 capital dr
monroe NC 28110
MDR Report Key9450077
MDR Text Key170248872
Report Number9450077
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 11/20/2019
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 Health Professional
Device Catalogue Number450225
Device Lot NumberA19024NX
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/20/2019
Event Location Hospital
Date Report to Manufacturer12/11/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/11/2019
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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