BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14685250 · Received June 14, 2022

    Report

    Report Number
    1125230-2022-00026
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Report Date
    June 20, 2022
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) A DATE OF THE EVENT COULD NOT BE OBTAINED FROM THE CUSTOMER. NO SAMPLES FOR EVALUATION WERE RECEIVED FROM THE CUSTOMER YET. AS SOON AS THE INVESTIGATION OF THE EVENT IS COMPLETED, A SUPPLEMENTARY REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE RECEIVED FOR EVALUATION. WE HAVE NO REMAINING INVENTORY OF THE MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THE MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED EVENT. THEREFORE, THE ALLEGED EVENT IS NOT JUSTIFIED. CORRECTED DATA: H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER STATES TUBES NOT COMPLETELY FILLING. THIS HAS CAUSED MULTIPLE PATIENTS TO BE REDRAWN A FEW TIMES. TECHNICAL SERVICES ADVISED THE CUSTOMER THAT THIS LOT NUMBER OF PRODUCT IS EXPIRED AND PROVIDED CUSTOMER WITH IFU HIGHLIGHTING "DO NOT USE TUBES PAST EXPIRATION". AFTER RECEIVING THIS INFORMATION, THE CUSTOMER STATED THAT THEY HADN'T LOOKED CLOSE AT ANY OF THE TUBES YET BUT THEY ARE DEFINITELY EXPIRED. THEY BELIEVE THE STORE ROOM GAVE THEM 2 SLEEVES OF THESE [TUBES] LAST WEEK WHEN THEY WERE RUNNING LOW. CUSTOMER STATED IT IS OBVIOUS THAT NO ONE CHECKED THE EXPIRATION DATE BEFORE PUTTING THEM INTO USE AND THIS WAS THEIR ERROR COMPLETELY. THE PHLEBOTOMISTS DIDN'T SAVE THE TUBES AND THEY WERE DISCARDED. THEY HAVE A FEW TUBES WITH PATIENT LABELS BUT THERE IS PHI ALL OVER THEM AND THE VENDOR LABELS UNDERNEATH ARE VERY HARD TO SEE AND TAKE A PHOTO. NO PHOTOS AND NO PRODUCT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750910 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75 EVACUATED BLOOD COLLECTION TUBE GIM GREINER BIO-ONE NA INC. 454334 B20083XR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown