BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75

    MDR report key: 17573393 · Received August 18, 2023

    Report

    Report Number
    1125230-2023-00044
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Report Date
    August 23, 2023
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE ONLY RECENTLY RECEIVED AND THEIR EVALUATION IS STILL ONGOING. AS SOON AS THE INVESTIGATION OF THE EVENT IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    COMPLAINT STATEMENT (B)(4): RECEIVED 7PCS 454334/B22113RC FOR EVALUATION. RECEIVED CUSTOMER PICTURES. WE HAVE NO REMAINING INVENTORY OF EITHER MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED ERROR. SAMPLES WERE TESTED, ACCORDING TO GBO STANDARD TESTING PROCEDURES, WITH REGARDS TO CORRECT ASSEMBLY 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 WERE VERIFIED TO BE CORRECTLY ASSEMBLED WITH NO DEVIATIONS OBSERVED. 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. THE ALLEGED MALFUNCTION IS NOT DUPLICATED. CORRECTED DATA: H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE TUBES UNDERFILLED. THE CUSTOMER ADVISED THEY USED A STRAIGHT NEEDLE AND DREW A DISCARD TUBE PRIOR TO THE COAGULATION TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127240 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454334 B22113RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown