MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE BLOOD COLLECTION TUBE SERUM; EVACUATED BLOOD COLLECTION TUBE

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No samples for evaluation were received.No material# nor batch # was provided by the customer.No clarification or further information was received from 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 a patient had a higher potassium value using the greiner sst relative to when the bd sst was used.

• Brand Name: VACUETTE BLOOD COLLECTION TUBE SERUM
• Type of Device: EVACUATED BLOOD COLLECTION TUBE
• Manufacturer (Section D): GREINER BIO-ONE NA INC.; 4238 capital drive; monroe NC 28110
• MDR Report Key: 12569047
• MDR Text Key: 283819132
• Report Number: 1125230-2021-00077
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K960858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/04/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1