BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAC 3.5ML 9NC COAG 3.2% BL-B NR SW HA US

    MDR report key: 21848295 · Received April 16, 2025

    Report

    Report Number
    1125230-2025-00012
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Report Date
    May 5, 2025
    Manufacturer
    GREINER BIO-ONE NORTH AMERICA, INC
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): SAMPLES HAVE BEEN REQUESTED FROM THE CUSTOMER BUT HAVE NOT YET BEEN RECEIVED AT THE TIME OF THIS REPORT. IF AND WHEN CUSTOMER SAMPLES ARE RECEIVED; THEY WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. UPON COMPLETION OF THE COMPLAINT INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4).: RECEIVED (B)(4) 454331/B240833T AND (B)(4) 454331/B240535C 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 COMPLAINT COULD NOT BE DUPLICATED. CORRECTED DATA: H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H11: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    WHILE PERFORMING ONSITE OBSERVATIONS WITH THE END CUSTOMER, THE GREINER BIO-ONE PRODUCT SPECIALIST TEAM REPORTED TO TS UNDERFILLING CONCERNS WITH THE PRODUCT. END CUSTOMER IS UC HEALTH PIKES PEAK REGIONAL HOSPITAL, RESIDING AT 8,900FT ELEVATION. OBSERVATIONS WERE PERFORMED WITH MULTIPLE VENIPUNCTURISTS COLLECTING BLOOD ON MULTIPLE PATIENTS. TUBES WERE HANDLED PER IFU PROCEDURES. PHOTOGRAPHS WERE TAKEN OF THE FILLED TUBES BEFORE AND AFTER CENTRIFUGATION. IN THE PHOTOGRAPHS, THE BLOOD FILL LINE PRIOR TO CENTRIFUGATION CONTAINED BUBBLES. PS TEAM SUSPECTED IF BUBBLES ARE NOT CONSIDERED AS PART OF THE SPECIMEN, THE TUBES WOULD NOT HAVE REACHED THE MINIMUM INDICATOR. TUBES WERE MARKED IN PHOTOS TO INDICATE THE START OF THE BUBBLES TO THE END OF THE BUBBLES. UNUSED PRODUCT SAMPLES WILL BE RETURNED FOR EVALUATION. DEVICES USED: 6 TUBES WERE COLLECTED VIA IV W/BD MAX-ZERO EXTENSION AND BD VACUTAINER LUER-LOCK ACCESS DEVICE. 1 TUBE COLLECTED VIA IV W/BD MAX-ZERO EXTENSION AND BLUE TOP LUER WITH STANDARD TUBE HOLDER. 1 COLLECTION WAS WITH THE MULTI-USE DRAW NEEDLE AND QUICKSHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111342 VAC 3.5ML 9NC COAG 3.2% BL-B NR SW HA US TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT GIM GREINER BIO-ONE NORTH AMERICA, INC 454331 B240833T, B240535C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown