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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE BLOOD TRANSFER DEVICE PP STERILE SPECIMEN CONTAINER

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GREINER BIO-ONE GMBH VACUETTE BLOOD TRANSFER DEVICE PP STERILE SPECIMEN CONTAINER Back to Search Results
Model Number 450225
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Complaint (b)(4). Received medwatch report on 02/26/2018 uf/importer report# 1600160000-2018-8003 no samples (actual or unused) or photos were received from customer. We have no further complaints on the material/batch. We forwarded the complaint to our affiliated headquarters in (b)(4) from which we receive this product. According to their investigation and comments, a review of production documentation of the concerned material/batch shows no deviations related to the reported error. A check of samples (of the concerned material/batch in gbo inventory) does not reveal any irregularities. The complaint cannot be confirmed.
 
Event Description
Customer reported that the protective needle broke off into the blood culture bottle (stopper) when transferring. Unsure if it (breakage) could cause contamination. No injury, blood exposure or other device breakage was reported. Customer used greiner device as a one-time substitute while the bd device was back ordered.
 
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Brand NameVACUETTE BLOOD TRANSFER DEVICE PP STERILE
Type of DeviceSPECIMEN CONTAINER
Manufacturer (Section D)
GREINER BIO-ONE GMBH
bad haller str. 32
kremsmuenster, upper austria 4550
AU 4550
Manufacturer (Section G)
GREINER BIO-ONE NA INC.
4238 capital drive
monroe NC 28110
Manufacturer Contact
manfred abel
bad haller str. 32
kremsmuenster, upper austria 4550
AU   4550
MDR Report Key10759009
MDR Text Key219546193
Report Number8020040-2018-00015
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
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 10/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2020
Device Model Number450225
Device Catalogue Number450225
Device Lot NumberA17103XD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2018
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 Unkown

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