MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE QUICKSHEILD COMPLETE PLUS 22G X 1.5"; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450228
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint number: (b)(4) (b)(6) 2018).Results and comments qa: no samples (actual or unused) were received for evaluation.Please advise the customer that we must have samples returned for quality assurance so that a proper investigation may be conducted.Should the customer encounter any issues in the future, please advise them to save the samples for investigative purposes.Received customer picture which is unfortunately out of focus making it difficult to discern anything.No material numbers were provided.No batch numbers were provided.No clarification or further information was received from the customer after multiple attempts.Unfortunately, without basic information, a thorough investigation is not possible.We have forwarded the complaint to our affiliated headquarters for their information.This complaint is closed as cannot be determined due to insufficient information.Please review the instructions for use on www.Gbo.Com sample received on june 12,2018- addendum to above.6/12/18 received material/batch information for the first claimed issue.We have no further complaints on the material/batch.We have no further inventory of the material/batch.6/20/18 received 1 inner box for 450228/g170537c for evaluation.We forwarded the complaint and samples to our affiliated headquarters in austria from which we receive this product.According to their investigation and comments, a review of production documentation of the reported material/batch shows no indications of deviations.No abnormalities were observed during in process control.The customer returned samples were visually checked; two incompletely screwed in needles were observed.Samples were functionally checked; spin out was observed in only one sample (one of the two incompletely screwed in needles).The complaint is confirmed.As a preventative measure, ultrasonic welding has been implemented in the assembly line to improve the connection between needle and holder.Please advise the customer to open the blister packaging with care and to fully remove the device from the packaging.Pay particular attention to not inadvertently hold the needle cap in place while removing the device.Do not use if product has sustained any transport damages.Please handle our products according to their instructions for use.
Event or Problem Description
Customer states needle has disconnected from the holder during phlebotomy; tubes flew off the needle and across the room; and cap popped off splattering blood on phlebotomist's face.

• Brand Name: VACUETTE QUICKSHEILD COMPLETE PLUS 22G X 1.5"
• 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: 9740435
• Report Number: 8020040-2018-00005
• Device Sequence Number: 11213081
• Product Code: FMI
• UDI-Device Identifier: 39120017577752
• UDI-Public: 39120017577752
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072320
• 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 Model Number: 450228
• Device Catalogue Number: 450228
• Device Lot Number: G170537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2018
• 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