MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VAC 5ML Z SERUM SEP C/A NR RED/Y 13X100, VAC 5ML LH LI HEP SEP NR GRN/Y 13X100; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 456073, 456087

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Test Result (2695)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint : (b)(4).Received loose tubes: 9 of 456073/b15033hx, 7 of 456087/b150535e, 6 of 456087/b15053f6 for evaluation.Additive content was found to be within specification in all tested samples.Samples were checked for potassium content and none could be detected.No deviations could be observed on the samples.We have no further complaints on the materials/batches.We were unable to confirm the complaint.

Event Description

Customer experiencing high potassium (17-25 mmol/l) and negative calcium on four separate patient results.Draws were conducted at a clinic (1), nursing home(1), and in-patients (2).Draw were either syringe or straight needle.

• Brand Name: VAC 5ML Z SERUM SEP C/A NR RED/Y 13X100, VAC 5ML LH LI HEP SEP NR GRN/Y 13X100
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• 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 ; 7042617800
• MDR Report Key: 10504773
• MDR Text Key: 207942347
• Report Number: 1125230-2015-00008
• 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: 08/09/2020

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: 09/30/2016
• Device Model Number: 456073, 456087
• Device Catalogue Number: 456073, 456087
• Device Lot Number: B15033HX, B150535E, B15053F6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2015
• Initial Date FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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