MAUDE Adverse Event Report: GREINER BIO-ONE GMBH UNKNOWN; BLOOD COLLECTION TUBES

Model Number UNKNOWN

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

Patient Problem Hemolysis (1886)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint no: (b)(4).No material number or batch number received from the customer.No samples were received for evaluation.Upon receipt of clarification on material/batch of the reported error we will file supplement report.At this time complaint can not be determined.

Event Description

Customer states they are experiencing hemolysis.They are having hemolyzed capillary specimens from the nicu department.

• Brand Name: UNKNOWN
• Type of Device: BLOOD COLLECTION TUBES
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32,; kremsmuenster, upper austria 4550 ; AU 4550
• 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: 10730435
• MDR Text Key: 219545930
• Report Number: 8020040-2020-00013
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1