BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11825240 · Received May 14, 2021

    Report

    Report Number
    1125230-2021-00046
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Report Date
    May 24, 2021
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 3PC 454334/B20103LN, 6PC 454322/B200735B, AND 8PC 454334/B20093A8 FOR EVALUATION. RECEIVED CUSTOMER PICTURES. ALSO RECEIVED A RANDOM ASSORTMENT OF ADDITIONAL MATERIALS/BATCHES WHICH ARE NOT PART OF THE COMPLAINT AND SOME OF WHICH ARE EXPIRED. WE HAVE NO FURTHER INVENTORY OF THE CLAIMED MATERIALS/BATCHES. 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, 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 WERE VERIFIED TO BE CORRECTLY ASSEMBLED AND HAD THE CORRECT FILL GUIDELINE 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. 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 H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION; INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 1

    (B)(4). A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE ONLY RECENTLY RECEIVED AND ARE NOT YET EVALUATED. AS SOON AS THE INVESTIGATION OF THE EVENT IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER STATES TUBES ARE UNDERFILLING TO ONE HALF INCH BELOW THE FILL REFERENCE MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725885 VACUETTE TUBE 9NC COAGULATION SODIUM CITRATE 3,2% 13X75 EVACUATED BLOOD COLLECTION TUBES GIM GREINER BIO-ONE NA INC. 454334, 454322 B20103LN, B20093A8, B200735B

    Patients

    Seq Age Sex Outcome Treatment
    1