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 Problem Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Complaint (b)(4).Received 1rk 454067p/b190338e for evaluation.We have no further inventory of the material/batch.Samples were tested, according to gbo standard testing procedures, with regards to correct assembly, level mark, filling level, draw volume according to iso 6710 'single use containers for venous blood specimen collection' and clsi gp39-a6 regulations for 'evacuated tubes and additives for blood specimen collection'.Tubes were verified to be correctly assembled and had the correct fill guide line position.Greiner fill mark provides a visual control opportunity for the phlebotomist and for the lab personnel to check for proper volume collection of specimen.Both standards specify the draw volume to be within +/- 10% range of the nominal fill volume.Five tubes were observed to short fill on the tested samples.Upon further evaluation of these five tubes, a deep scratch was observed on the interior tube walls.All remaining tubes tested filled within the +/-10% tolerance range.The complaint is confirmed.Scratches extending from below the rubber stopper to the top of the tube may lead to vacuum loss.Repairs had been made to the grippers to stop them from shifting tubes in the workpiece carrier which could result in scratched tubes.Maintenance has inspected the production machine with regards to the functionality of grippers.As some wear was observed, several springs and inserts were replaced to ensure the gripper assembly is functioning ideally.

Event Description

Customer states the tubes appear to have no vacuum.

• 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: 10819725
• MDR Text Key: 219522603
• Report Number: 1125230-2019-00008
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960858
• 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: Repair
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 09/04/2019
• 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
• Patient Sequence Number: 1