MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE TUBE 5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X100 GOLD CAP-GOLD RING; VACUETTE BLOOD COLLECTION TUBES SERUM

Model Number 456018P

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint: (b)(4).Customer did not returned suspected device for evaluation.We received samples from same material/batch for evaluation.A review of quality, production, maintenance records revealed no deviations.The 205 loose tubes of 456018p/b2003399 were all visually inspected.Of the 205 loose tubes, fourteen appeared to have no visible bca additive within the tubes.The remaining 191 tubes had a visible spray pattern, and no other visual deviations were found.No visual deviation found, draw volume, level mark and additive for all sample tubes were found within the tolerance.

Event Description

Customer states that some specimens are not properly clotting.They allowed sample to clot for 30 minutes and some of them are not clotted an hour after collection.Customer advises that after spun down, big "boogers" appear in tubes.They have to use a pipette to remove the "booger" so testing can be performed.".

• Brand Name: VACUETTE TUBE 5 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 13X100 GOLD CAP-GOLD RING
• Type of Device: VACUETTE BLOOD COLLECTION TUBES SERUM
• Manufacturer (Section D): GREINER BIO-ONE NA INC; 4238 capital drive; monroe, nc
• Manufacturer (Section G): GREINER BIO-ONE NA INC; 4238 capital drive; monroe, nc
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, nc ; 2617823
• MDR Report Key: 10403512
• MDR Text Key: 204933274
• Report Number: 1125230-2020-00004
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050028
• 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
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2021
• Device Model Number: 456018P
• Device Catalogue Number: 456018P
• Device Lot Number: B2003399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1