MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE® QUICKSHIELD SAFETY TUBE HOLDER

Model Number	450230
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have no further complaints on the material/batch.We have no further inventory of the material/batch.No error reported with the product, incident due to handling error by the phlebotomist.The complaint was filed for documentation purposes due to the needlestick.
Event or Problem Description
Customer states there was a needlestick when engaging the quickshield guard.Phlebotomist's thumb slipped off the quickshield guard and the needle tip scraped the side of the thumb.It ripped through the glove and broke the skin.

• Brand Name: VACUETTE® QUICKSHIELD SAFETY TUBE HOLDER
• Common Device Name: VACUETTE® QUICKSHIELD SAFETY TUBE HOLDER
• Manufacturer (Section D): GREINER BIO-ONE NA INC; 4238 capital drive; monroe NC 28110
• MDR Report Key: 9566709
• Report Number: 8020040-2019-00001
• Device Sequence Number: 2860629
• Product Code: FMI
• UDI-Device Identifier: 39120017570982
• UDI-Public: 39120017570982
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K033478
• 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): 01/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: 450230
• Device Catalogue Number: 450230
• Device Lot Number: B190237D
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1