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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 5ML Z SERUM SEP C/A NR BLK-L GLD/GLD; EVACUATED BLOOD COLLECTION TUBE

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GREINER BIO-ONE NA INC. VACUETTE 5ML Z SERUM SEP C/A NR BLK-L GLD/GLD; EVACUATED BLOOD COLLECTION TUBE Back to Search Results
Model Number 456018P
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complaint (b)(4).No samples were received for evaluation.No pictures were received.We have no further inventory of the material/batch.A check of quality, production and maintenance records shows no deviations related to the reported issue.The complaint cannot be determined.
 
Event Description
Customer advised they are experiencing an increasing trend in the number of hemolyzed specimens since converting to vacuette tubes in (b)(6) 2019.Customer states centrifugation is 5126rcf for 3 minutes on a statspin express3.Centrifugation is performed usually within 1 hour of specimen collection.Customer advised 35% of chemistry specimens are to half or less of the nominal.Rejected hemolyzed samples occur with properly filled specimens and specimens filled half or less of the nominal.
 
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Brand Name
VACUETTE 5ML Z SERUM SEP C/A NR BLK-L GLD/GLD
Type of Device
EVACUATED BLOOD COLLECTION TUBE
Manufacturer (Section D)
GREINER BIO-ONE NA INC.
4238 capital drive
monroe NC 28110
Manufacturer (Section G)
GREINER BIO-ONE NA INC.
4238 capital drive
monroe NC 28110
Manufacturer Contact
manfred abel
4238 capital drive
monroe, NC 28110
7042617823
MDR Report Key10856250
MDR Text Key226641749
Report Number1125230-2020-00048
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K983952
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2020
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 Expiration Date02/09/2021
Device Model Number456018P
Device Catalogue Number456018P
Device Lot NumberB1909355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/13/2020
Initial Date FDA Received11/17/2020
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 Unknown
Patient Sequence Number1
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