MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE® LUER ADAPTER 20G; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450070
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	04/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number (b)(4).Internal investigations of the product did not show any deviations.Since the application that led to the incident is not recommended in the instructions for use and no product defects were determined, the cause could not be on the product.As the incident was not caused by a malfunction or a fault in the product and the permitted use of the product is sufficiently described in the instructions for use, no more corrective actions will be taken.
Event or Problem Description
A nurse tried to remove the vacuette luer adapter from a venflon and a needle stick injury with tube-side needle occurred.The nurse received (b)(6) prophylactic treatment.

• Brand Name: VACUETTE® LUER ADAPTER 20G
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 32 bad haller strasse; kremsmuenster, 4550 ; AU 4550
• MDR Report Key: 9745733
• Report Number: 8020040-2018-00011
• Device Sequence Number: 1802422
• Product Code: FMI
• UDI-Device Identifier: 29120017570176
• UDI-Public: 29120017570176
• Combination Product (Y/N): N
• PMA/510(K) Number: K981619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 450070
• Device Catalogue Number: 450070
• Device Lot Number: 17A19A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 02/24/2020
• 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