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

Model Number 455071P

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer states clotting issues.Samples were left to clot for 45-50 minutes and vials from this lot number were spun in different centrifuges to make sure it wasn't the centrifuge.Pictures are provided.More information requested.

Manufacturer Narrative

Complaint (b)(4).A date of the event could not be obtained.Samples were only recently received and are still under evaluation.As soon as the investigation of the event is completed, a supplemental report will be filed.

Manufacturer Narrative

Complaint statement (b)(4).Received 6pc 455071p/b220737s for evaluation.Also received 19pcs 455071p/b220739m, 8pcs 455071p/b220534h and 1082pcs 455071p/b220833p, which were unrelated to the complaint.We have no remaining inventory of this material/batch.We have no further complaints on the material/batch.A check of quality, production, and maintenance records revealed no deviations in relation to the reported error.Additive content was found to be within specification in all tested samples.Some of the customer samples were evaluated in a blood draw.Gel barriers formed correctly, and good separation was observed in the tested samples when samples were allowed to clot thoroughly and centrifuged using recommended gbo parameters within 2 hours of collection.The alleged malfunction is not duplicated.

• 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 NA INC.; 4238 capital drive; monroe NC 28110
• 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: 15886613
• MDR Text Key: 307768406
• Report Number: 1125230-2022-00050
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2023
• Device Model Number: 455071P
• Device Catalogue Number: 455071P
• Device Lot Number: B220737S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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