MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE TUBE 5ML Z SERUM SEP CLOT ACTIVATOR RED CAP YELLOW RING 456300PS460; GREINER VACUATTE BLOOD COLLECTION TUBE

Model Number	456073P
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	06/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).We have no further complaints on the material/batch.We have no further inventory of the material/batch.A review of production and quality records shows no deviations which could be related to the reported event.8/22- received 1 pc 456073p/b17043e5 for evaluation.The actual sample with which the incident occurred was not received.Sample was evaluated, according to gbo standard testing procedures, with regards to correct assembly, level mark, draw volume and additive content.Tube was verified to be correctly assembled and had the correct fill guide line position.Greiner fill mark provides a visual control opportunity for the phlebotomist and for the lab personnel to check for proper volume collection of specimen.No visual deviations (no damages to tube nor to cap) were observed.All parameters were found to be within tolerance and specification.Several qa/qc personnel were involved in the evaluation and no abnormalities were noted.The cap did not pop off at any point during the handling and evaluation of the customer returned sample.The complaint could not be confirmed.Further comments: in general, tubes should not be decapped and recapped.When filling tubes via a syringe/blood transfer unit (as indicated by the customer), please be sure to refer to the ifu and allow the blood to freely transfer into the tube.Do not press the plunger of the syringe and create positive pressure.The vacuum in the tube will draw the blood into the tube.We appreciate it being brought to our attention as we continuously strive to improve greiner products and services.
Event or Problem Description
Customer states nurse was gently rotating gold top tube of blood specimen back and forth while walking.Nurses advised that the top of the tube popped-off.Blood splattered onto the nurse's face including lip (but not in eyes or mouth), on neck, shirt, and right arm.Blood also sprayed on the floor.Nurse immediately washed all splattered areas of body with soap and water.Nurse was referred to hospital policy regarding employee exposure to blood-borne pathogens and sent the nurse to employee health.

• Brand Name: VACUETTE TUBE 5ML Z SERUM SEP CLOT ACTIVATOR RED CAP YELLOW RING 456300PS460
• Common Device Name: GREINER VACUATTE BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32; kremsmuenster, 4550 ; AU 4550
• MDR Report Key: 9739247
• Report Number: 8020040-2017-00008
• Device Sequence Number: 1802420
• Product Code: JKA
• UDI-Device Identifier: 39120017572894
• UDI-Public: 39120017572894
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K983952
• 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): 02/20/2020

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: 10/07/2018
• Device Model Number: 456073P
• Device Catalogue Number: 456073P
• Device Lot Number: B17043E5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2017
• 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: Other