MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR13X100GREEN CAP-YELLOW RING; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 456087P

Device Problem Improper Chemical Reaction (2952)

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

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).No samples were received for evaluation.No pictures were provided by customer.No batch # was provided by the customer.Unfortunately, without basic information, a thorough investigation is not possible.This complaint is closed as cannot be determined due to insufficient information.

Event Description

Customer states hemolysis issues with heparin tubes.

• Brand Name: VACUETTE TUBE 5 ML LH LITHIUM HEPARIN SEPARATOR13X100GREEN CAP-YELLOW RING
• 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: 10627619
• MDR Text Key: 219183389
• Report Number: 1125230-2019-00001
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960857
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 456087P
• Device Catalogue Number: 456087P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2019
• 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: Initial
• Patient Sequence Number: 1