MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100; EVACUATED BLOOD COLLECTION TUBE

Model Number 455071P

Device Problem Output Problem (3005)

Patient Problem Hemolysis (1886)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A date of the event could not be obtained from the customer.We only recently received samples, which were forwarded for evaluation to the headquarter where we purchase the product from.As soon as the investigation is completed, a supplemental report will be filed.

Event Description

Customer states hemolysis.The photo provided is from a draw on the same patient, same collection, using the greiner needle and tube and a smaller non greiner tube for the pour off.There were no difficulties with the draw.The psr [phlebotomist] has been with quest for over 20 years and very skills in phlebotomy.The increase in hemolyzed samples for chemistries continue to greatly impact their tnps [test not performed] and are of great concern.The used centrifuge in use is the drucker 642e.Horizon 642e.Approximate percentage of tubes displaying hemolysis 12-15 samples per week (at times).The tourniquet is applied for <1minute.Tubes are all filled to fill mark.

Manufacturer Narrative

Received 1 rack of 455071p/a22034pa for evaluation.We have no remaining inventory of the material/batch.We have no further complaints for the material/batch.We forwarded the complaint, customer samples and customer picture to our affiliated headquarters in austria from which we receive this product.According to their investigation and comments, a check of all relevant process parameters did not reveal any deviations which could be associated with the complained errors.Customer samples were evaluated, and no deviations related to the claimed issue were observed.The alleged malfunction cannot be confirmed.Corrected data: h3: samples received; h6: type of investigation, investigation findings, investigation conclusion; h10 manufacturer narrative.

• Brand Name: VACUETTE® TUBE 8 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller str. 32; kremsmuenster, upper austria 4550 ; AU 4550
• Manufacturer (Section G): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617823
• MDR Report Key: 15089034
• MDR Text Key: 302014894
• Report Number: 8020040-2022-00022
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Device Lot Number: A22034PA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1