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 Code	Exposure to Body Fluids (1745)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number: (b)(4).Received 1 pc 450082/17l03u for evaluation.The actual sample was not received.No customer pictures were received.We have no further complaints on the material/batch.We have no further inventory of the material/batch.We forwarded the complaint and sample to our supplier for their investigation and comments.A check of 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.Functional testing was performed.Move force, pull force between stopper + safety protector and hub + safety protector (after lock) and return force (after lock) were all measured; all results were within specification.Samples were functionally tested by penetrating an artificial arm, simulating blood collection and then activating the safety mechanisms.No abnormalities such as safety mechanism releasing or device twisting back on itself were observed.Tested samples were found to work properly, lock with audible click and needles were fully retracted.The complaint cannot be confirmed.Further comments: please review the instructions for use.Do not use if product has sustained any transport damages.Engage the safety mechanism with activation as described in the ifu.Do not forcefully release or re-activate the safety mechanism after it has been activated.Do not attempt to tamper with the safety mechanism after activation.Promptly dispose of the vacuette safety blood collection/infusion set in an approved disposal container in accordance with the procedures of your facility.Refer the customer to the ifu.
Event or Problem Description
Customer advised that when phlebotomist used the device it would twist back onto itself requiring the phlebotomist to anchor the device while terminating the venipuncture and removing the needle from the patient's arm.Customer stated that upon terminating the venipuncture and activating the safety mechanism, the needle did not fully retract as designed.Customer confirmed a needle related blood exposure occurred but there was no injury or medical intervention required.Customer added that the needle not retracting as design has happened with other phlebotomists but could not advise number of occurrences.Customer confirmed they have had only the identified lot number in use.

• 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,, 4550 ; AU 4550
• MDR Report Key: 9741172
• Report Number: 8020040-2018-00008
• Device Sequence Number: 19283167
• Product Code: FMI
• UDI-Device Identifier: 39120017570241
• UDI-Public: 39120017570241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 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
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 450082
• Device Catalogue Number: 450082
• Device Lot Number: 17L03U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2018
• 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