MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE5ML Z SERUM SEP C/A NR BLK-L GLD/GLD; EVACUATED BLOOD COLLECTION TUBE

Model Number 456018P

Device Problems Coagulation in Device or Device Ingredient (1096); Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No samples were received for evaluation.No pictures were 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 august 2019.Customer states centrifugation is 1820rcf for 10 minutes and performed within 1 hour of specimen collection.Customer advises most specimens were full to half-full in the tube.The collection method used on specimens hemolyzed, medsurge uses butterfly, ed usually uses vascular access devices.

• Brand Name: VACUETTE5ML 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: 10856230
• MDR Text Key: 218574556
• Report Number: 1125230-2020-00047
• 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: 02/19/2021
• Device Model Number: 456018P
• Device Catalogue Number: 456018P
• Device Lot Number: B1910355
• 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