MAUDE Adverse Event Report: GREINER BIO-ONE GMBH SAFETY BLOOD COLLECTION SET HOLDER 23GX19CM SP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450086
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number: (b)(4).Received 1 pc 450086/17h09u for evaluation.Actual sample was not received.Received customer pictures.We have no further complaints on the material/batch.We have no further inventory of the material/batch.We forwarded the complaint, sample and pictures to our supplier for their investigation and comments.Documents of the concerned material/batch were reviewed and no documentation indicating the deviation could be observed.Customer and retain samples were visually inspected.No defects in any components or connecting areas could be observed.They were functionally evaluated by stimulating a blood collection where three blood collection tubes were filled per sbcs.No leakage within the holders could be observed and no separation of the rubber sleeves from the devices could be observed.Then the pull force at the connection of the rubber sleeve and the hub was measured.All results were within specification.The complaint could not be confirmed.
Event or Problem Description
Customer states an rn removed the tubing and needle from the greiner bio one blood collection set, leaving the luer connected to the tube holder.She started an iv and connected the luer and tube holder of the greiner bio one directly to the hub of the iv catheter.A large amount of blood began flowing out from the needle inside the tube holder.The rn was able to collect three tubes of blood.Between each tube collection, blood continued to flow from the needle inside the tube holder.At some point during this blood collection process, the rn felt a needlestick to right thumb.The rn thinks that her thumb must have slipped inside the needle holder and been punctured because there was no other needle exposed.During clean-up, the rn found the grey rubber sheath that normally covers the needle inside the tube holder on the floor about six feet away.Customer confirms this was a vascular draw.Customer answered no to all decision tree questions.

• Brand Name: SAFETY BLOOD COLLECTION SET HOLDER 23GX19CM 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: 9740716
• Report Number: 8020040-2018-00006
• Device Sequence Number: 16594880
• Product Code: FMI
• UDI-Device Identifier: 39120017570289
• UDI-Public: 39120017570289
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/21/2020

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: 07/31/2020
• Device Model Number: 450086
• Device Catalogue Number: 450086
• Device Lot Number: 17H09U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2018
• 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