MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 454209CA

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Gbo complaint: (b)(4).We received customer pictures and received 24rk and 375 loose tubes of item 454209ca/ lot b16013cw for evaluation.We have no further inventory of the material/batch.The complaint is confirmed.Recall was initiated.

Event Description

Customer states that some tubes contain liquid as opposed to spray-dried edta.This was discovered when the facility was troubleshooting erroneous average glomerular volume results on four different patients.The internal investigation at the facility found that the tubes containing liquid additive gave a hi her result, for a mean of 10 fl, on this parameter.

• Brand Name: VACUETTE TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED
• 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: 10652332
• MDR Text Key: 211565157
• Report Number: 1125230-2016-00007
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K971236
• 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: 10/08/2020

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
• Device Expiration Date: 07/01/2017
• Device Model Number: 454209CA
• Device Catalogue Number: 454209CA
• Device Lot Number: B16013CW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 10/08/2020
• 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