MAUDE Adverse Event Report: GREINER BIO-ONE NA INC. VACUETTE 4ML Z SERUM SEP C/A NR RED/Y13X75; EVACUATED BLOOD COLLECTION TUBE

Model Number 454067P

Device Problems Nonstandard Device (1420); Short Fill (1575)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Received 3rk 454067p/b190338e for evaluation.We have no further inventory of the material/batch.The complaint is confirmed.

Event Description

Customer advised they are experiencing specimens under filling.

• Brand Name: VACUETTE 4ML Z SERUM SEP C/A NR RED/Y13X75
• 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: 10833941
• MDR Text Key: 227652275
• Report Number: 1125230-2019-00014
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2020
• Device Model Number: 454067P
• Device Catalogue Number: 454067P
• Device Lot Number: B190338E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1125230-11/22/2019-001-R
• Patient Sequence Number: 1