MAUDE Adverse Event Report: GREINER BIO-ONE NA INC SAFETY BLOOD COLLECTION SET + LUER ADAPTER 23G X 3/4" TUBING LENGTH 12" (30 CM); NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450096
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received 1 inner box 450096/18k10u for evaluation.We have no further complaints on the material/batch.We have no further inventory of the material/batch.We forwarded the complaints and samples to our supplier for their investigation and comments.A check of the production records of the concerned material/batch shows no documentation indicating a deviation.Customer and retain samples were visually inspected; no defects were observed in the safety lock parts for any of the checked samples.The safety mechanism were activated.They were found to work properly and lock with audible click.The lock protectors were manually manipulated but the safety lock mechanism did not release back.Functional testing was performed.Move force, pull force between stopper + safety protector and hub + safety protector (after lock) and returned force (after lock) were all measured; all results were within specification.The complaint cant be confirmed.
Event or Problem Description
Customer states a needlestick occured.The phlebotomist tried to activate the device by sliding it back but it stuck, so she pulled the needle out of patient then stuck her finger.One other phlebotomist mentioned possible sticky activation.

• Brand Name: SAFETY BLOOD COLLECTION SET + LUER ADAPTER 23G X 3/4" TUBING LENGTH 12" (30 CM)
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE NA INC; 4238 capital drive; monroe NC 28110
• MDR Report Key: 9566745
• Report Number: 8020040-2019-00002
• Device Sequence Number: 10844746
• Product Code: FMI
• UDI-Device Identifier: 39120017570340
• UDI-Public: 39120017570340
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K121908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 11/01/2021
• Device Model Number: 450096
• Device Catalogue Number: 450096
• Device Lot Number: 18K10U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1