BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE TUBE 2 ML K2E K2EDTA 13X75 LAVENDER CAP-WHITE RING, NON-RIDGED, USA

    MDR report key: 11207401 · Received January 21, 2021

    Report

    Report Number
    1125230-2021-00003
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Report Date
    February 11, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    JKA
    PMA / PMN Number
    K971236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED TEN LOOSE TUBES OF 454428/B20083SV RETURNED FROM THE CUSTOMER. RECEIVED CUSTOMER PICTURES. WE HAVE NO REMAINING INVENTORY FOR THIS MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THIS MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE DOCUMENTS REVEALED NO DEVIATIONS IN RELATION THE REPORTED EVENT. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO LEVEL MARK, FILLING LEVEL AND 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 HAD THE CORRECT FILL LINE GUIDE POSITION. GREINER FILL MARK PROVIDES A VISUAL CONTROL OPPORTUNITY FOR THE PHLEBOTOMIST AND FOR THE LAB PERSONNEL TO CHECK FOR PROPER VOLUME COLLECTION OF SPECIMENS. BOTH STANDARDS SPECIFY THE DRAW VOLUME TO BE WITHIN +/- 10% RANGE OF THE NOMINAL FILL VOLUME. NO VISUAL DEVIATION IN FILL VOLUME, SPORADIC LOW OR HIGH FILL, COULD BE OBSERVED IN THE TESTED SAMPLES. ALL TUBES TESTED FILLED WITHIN THE +/-10% TOLERANCE RANGE. NO SHORT FILLING COULD BE OBSERVED ON THE SAMPLES. THE COMPLAINT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    COMPLAINT (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. RETURNED SAMPLES HAVE NOT YET BEEN INVESTIGATES. AS SOON AS THE INVESTIGATION OF THE EVENT IS COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE HAVING ISSUES WITH UNDERFILLING TUBES. THE REPORTS ARE COMING FROM EXPERIENCED LAB PEOPLE. ISSUES OCCUR WITH STRAIGHT NEEDLE, BUTTERFLY, AND SYRINGE WITH TRANSFER DEVICE. NO DISCARD TUBE IS USED FOR A BUTTERFLY DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108332 VACUETTE TUBE 2 ML K2E K2EDTA 13X75 LAVENDER CAP-WHITE RING, NON-RIDGED, USA EVACUATED BLOOD COLLECTION TUBE JKA GREINER BIO-ONE NA INC. 454428 B20083SV

    Patients

    Seq Age Sex Outcome Treatment
    1