MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 5ML Z SERUM SEP C/A NR BLK-L GLD/GLD; EVACUATED BLOOD COLLECTION TUBE

Model Number 456018P

Device Problems Short Fill (1575); Improper Chemical Reaction (2952)

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

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).No samples were received for evaluation.Customer picture was received.A check of quality, production and maintenance records shows no deviations related to the reported issue.The complaint cannot be determined.

Event Description

Customer advised they are experiencing an increasing trend in the number of hemolyzed specimens since converting to vacuette tubes in (b)(6) 2019.Customer states centrifugation is 4041rcf for 5 minutes on a statspin express4.Centrifugation is performed within 2 hour of specimen collection and outreach clinics centrifuge before sending in their specimens.Customer said most specimens are half-filled or less to the nominal.Customer advised phlebotomist draw specimens with straight needles and butterfly, the ed collects through vascular access devices.

• Brand Name: VACUETTE 5ML Z SERUM SEP C/A NR BLK-L GLD/GLD
• 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: 10856223
• MDR Text Key: 226642445
• Report Number: 1125230-2020-00049
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983952
• 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: 11/17/2020

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: 02/09/2020
• Device Model Number: 456018P
• Device Catalogue Number: 456018P
• Device Lot Number: B1909355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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