MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VAC QUICKSHIELD COMPLETE PLUS 22GX 1.5"; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450228
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number: (b)(4).No samples were received.Please advise the customer that we must have samples returned for quality assurance so that a proper investigation may be conducted.Should the customer encounter any issues in the future, please advise them to save the samples for investigative purposes.Received customer pictures.We have no further inventory of the material/batch.We have no further complaints on the material/batch.We forwarded the complaint and pictures to our affiliated headquarters in (b)(4) from which we receive this product.According to their investigation and comments, a review of the production and testing documents indicated no deviations concerning the reported error.No abnormalities occurred during the entire manufacturing process or in process control.In addition, during final checking, which includes functional tests, no irregularities were revealed.The complaint cannot be determined.
Event or Problem Description
Customer states: "the needle bends excessively while activating the safety shield.This has been a continuous complaint from all my phlebotomist.There have been 4 recent incidents where the needle has bent out of the safety shield while being activated and safety click was heard.One incident resulted in one of the phlebotomist being stuck with a used needle.The phlebotomist activated the shield and heard the click.She placed the vacuette down bedside to bandage the patient and was stuck when she reached to dispose of the vacuette.".

• Brand Name: VAC QUICKSHIELD COMPLETE PLUS 22GX 1.5"
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32; kremsmuenster, austria 4550 ; AU 4550
• MDR Report Key: 9720563
• Report Number: 8020040-2016-00017
• Device Sequence Number: 329610
• Product Code: FMI
• UDI-Device Identifier: 39120017577752
• UDI-Public: 39120017577752
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 450228
• Device Catalogue Number: 450228
• Device Lot Number: G16043BK
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention