MAUDE Adverse Event Report: GREINER BIO-ONE GMBH SAFETY BLOOD COLLECTION SET + LUER ADAPTER 23G X 30CM SP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450096
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(complaint number: (b)(4)).No samples (actual or unused) were received for evaluation.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.No pictures were received.No batch # was provided by the customer.Unfortunately, without basic information, a thorough investigation is not possible.This complaint is now closed as cannot be determined due to insufficient information.
Event or Problem Description
Customer advised that upon determination of the blood draw the phlebotomist placed the gauze over the puncture site, anchored it with finger, and activated the safety by pulling back on the safety mechanism.The needle did not fully retract and was exposed sticking the phlebotomist's finger used to anchor the gauze.Phlebotomist could not remember if he heard/felt the safety click into place.

• Brand Name: SAFETY BLOOD COLLECTION SET + LUER ADAPTER 23G X 30CM SP
• 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: 9727667
• Report Number: 8020040-2017-00002
• Device Sequence Number: 11494816
• Product Code: FMI
• UDI-Device Identifier: 39120017570340
• UDI-Public: 39120017570340
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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: 450096
• Device Catalogue Number: 450096
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 02/19/2020
• 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