MAUDE Adverse Event Report: GREINER BIO-ONE GMBH SAFETY BLOOD COLLECTION SET + LUER ADAPTER 21GX30CM SP; SAFETY INFUSION SET

Model Number	450095
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(complaint number: (b)(4)).Received 450095/16l25u: 100 pc unused, 2 pc used for evaluation.Received customer picture.The customer is not reporting issues with the devices involved in the needlesticks.We have no further inventory of the material/batch.We have no further complaints on the material/batch.We forwarded the complaint, samples and picture to our supplier for their investigation and comments.A check of quality documents shows no documentation indicating a deviation.Retain samples and unused customer samples were visually inspected; no defects in any of the components could be observed.Samples were functionally tested by penetrating an artificial arm and activating the safety mechanisms; they were found to work properly and locked without damaging components.The complaint cannot be confirmed.From the appearance of the used samples, it was surmised that the hubs may have been broken due to excessive bending force during operation.Model tests confirm that by bending the hub manually during activation of the safety mechanism, the hub can be broken.Therefore it is believed that the cause of the customer's broken sbcs stemmed from undue force during activation of the safety mechanism that led to distortion and subsequent breakage of the hub.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.We appreciate it being brought to our attention as we continuously strive to improve greiner produts and services.
Event or Problem Description
Customer states there have been 3 needle stick incidents.In all three needle stick incidents, each phlebotomist was engaging the safety with her right hand and stuck a finger on her left hand.Customer states there have been 2 events of butterfly needles breaking away from the end of the safety.Customer advises all instances of needle stick and needle breakage events were not life threatening; no permanent impairment of body function; no permanent damage to a body structure; and no medical or surgical intervention needed.

• Brand Name: SAFETY BLOOD COLLECTION SET + LUER ADAPTER 21GX30CM SP
• Common Device Name: SAFETY INFUSION SET
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32; kremsmuenster, austria 4550 ; AU 4550
• MDR Report Key: 9738961
• Report Number: 8020040-2017-00006
• Device Sequence Number: 13903771
• Product Code: FMI
• UDI-Device Identifier: 39120017570333
• UDI-Public: 39120017570333
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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 Health Care Professional
• 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: 02/08/2020
• Device Model Number: 450095
• Device Catalogue Number: 450095
• Device Lot Number: 16L25U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2017
• 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