MAUDE Adverse Event Report: GREINER BIO-ONE GMBH SAFETY BLOOD COLLECTION SET + LUER ADAPTER 23G X 3/4 "; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450082
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(complaint number: (b)(4)) received 1 pc 450082/17b14u (and 1 pc 450099/unknown batch, not part of complaint) for evaluation.We have no further inventory of the material/batch.We have no further complaints on the material/batch.We forwarded the complaint and sample to our supplier for investigation and comments.Documents of the concerned batch were reviewed and there is no documentation which indicates a deviation.Retain samples were visually inspected and no defects were observed in the safety parts for any of the checked samples.The safety mechanisms were activated.They were found to work properly and lock with audible click.The locked protectors were manually manipulated but the safety lock mechanisms did not release back.Functional testing was performed.Move force, pull force between stopper + protector and hub + protector (after lock) and return force (after lock) were all measured; all results were within specification.Functional testing was performed on the returned customer sample.All results were within specification.The complaint could not be confirmed.
Event or Problem Description
Customer states a nurse was unable to sheath needle completely when removing the needle from the patient's arm and was stuck with needle.The nurse was using two-hands.In a separate incident, the customer advised the needle stick occurred when a nurse was attempting to remove sponge covered tip during a syringe blood draw.Customer confirmed there was no life-threatening, impairment, permanent, or necessary surgical intervention with these incidents.

• Brand Name: SAFETY BLOOD COLLECTION SET + LUER ADAPTER 23G X 3/4 "
• 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: 9732217
• Report Number: 8020040-2017-00003
• Device Sequence Number: 10851574
• Product Code: FMI
• UDI-Device Identifier: 39120017570241
• UDI-Public: 39120017570241
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 02/20/2020

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 Expiration Date: 01/31/2020
• Device Model Number: 450082
• Device Catalogue Number: 450082
• Device Lot Number: 17B14U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 02/20/2020
• 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