MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE VISIO PLUS NEEDLE21GX1 1/2"AND 22GX1 1/2". VAC QUICKSHIELD SAFETYHOLDER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450040, 450041, 450230
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number: (b)(4).Received 1 inner box of 450040/17b22b, 1 inner box of 450041/17c25b and 39 pieces of 450230/unknown batch for evaluation.No further details were provided by the customer regarding the injury except that it occurred with a competitor (bd) butterfly and not with a greiner needle.No batch # was provided for the holder.Unfortunately, without basic information, a thorough investigation is not possible.We have no further inventory of the materials/batches of needles.We forwarded the complaint and some of the samples to our affiliated headquarters in (b)(4) from which we receive the holders.The customer returned samples were visually checked; no indications of any abnormalities.Samples were functionally checked; reported error could not be reproduced.They could not confirm the complaint.We forwarded the complaint and some of the samples to our supplier from which we receive the needles.According to their investigation and comments, manufacturing and inspection records of the concerned materials/batches were reviewed and no abnormalities which could be related to the reported event were observed.Retain and customer samples were examined visually and no abnormality such as molding defect or damage to the needle hubs could be observed.Screwing torque was measured using greiner standard holders.The maximum on retain samples of 17b22b was 0.69kgf/cm, on retain samples of 17c25b was 0.68kgf/cm and on customer samples 0.81 kgf/cm.All samples were screwed into holders without any problems.Ted greiner blood collection tubes were inserted onto each tested sample and no spin out could be observed.They could not confirm the complaint.Further comments: the entire production process for the needles (from product assembly to packaging) is performed by automatic assembly machines.In the manufacturing process, molded parts are inspected per lot and only parts which pass are utilized.No process applies any damage to the hub during manufacturing.Appearance, dimension and function are checked per lot during in process inspection and release inspection.Any samples used for inspections are discarded.Please make sure that the needle is threaded perpendicularly into the holder.Angled threading of the needle can result in damage to the thread of the holder and needle.Ensure the needle is firmly seated so that it does not unthread during use.
Event or Problem Description
Customer states needle has disconnected from the holder before and during phlebotomy; today's incident resulted in a patient injury.Customer confirms needle does not break, but disconnects.Customer states "no" to all exposure/injury questions.Training was performed by sales rep.

• Brand Name: VACUETTE VISIO PLUS NEEDLE21GX1 1/2"AND 22GX1 1/2". VAC QUICKSHIELD SAFETYHOLDER
• 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: 9739881
• Report Number: 8020040-2018-00004
• Device Sequence Number: 13903759
• Product Code: FMI
• UDI-Device Identifier: 49120017570057
• UDI-Public: 49120017570057
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061483
• 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
• Operator of Device: Health Professional
• Device Model Number: 450040, 450041, 450230
• Device Catalogue Number: 450040, 450041, 450230
• Device Lot Number: 17B22B, 17C25B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2018
• 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