MAUDE Adverse Event Report: GREINER BIO-ONE GMBH SAFETY BLOOD COLLECTION SET+HOLDER 23GX30CM; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450161
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number: (b)(4).No batch number was provided.Customer has multiple batches in use and cannot determine which one was involved in this incident.Unfortunately, without basic information, a thorough investigation is not possible.We have forwarded the complaint to our supplier for their information.This complaint is closed as cannot be determined due to insufficient information.
Event or Problem Description
Customer is reporting a needle stick.Phlebotomist thought the safety device was activated after the stick.When gathering supplies he felt the sharp.The needle slid had out of the protection sheath and stuck his hand.Customer stated they do not believe this was a user error.Customer advised they place reference items in stock bins prior to use and the bins can contain multiple lot numbers.Customer states they have several lots in use and cannot identify which lot was associated with the injury.

• Brand Name: SAFETY BLOOD COLLECTION SET+HOLDER 23GX30CM
• 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: 9740862
• Report Number: 8020040-2018-00007
• Device Sequence Number: 1802197
• Product Code: FMI
• UDI-Device Identifier: 39120049202417
• UDI-Public: 39120049202417
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K011786
• 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): 02/21/2020

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: 450161
• Device Catalogue Number: 450161
• Device Lot Number: NO INFROMATION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 02/21/2020
• 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