BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14603913 · Received June 6, 2022

    Report

    Report Number
    1125230-2022-00023
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Report Date
    June 14, 2022
    Manufacturer
    GREINER BIO-ONE NA INC.
    Product Code
    GIM
    PMA / PMN Number
    K971221
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). DATES OF THE EVENTS COULD NOT BE OBTAINED FROM THE CUSTOMER. SAMPLES WERE ONLY RECENTLY RECEIVED AND THE EVALUATION IS STILL IN PROGRESS. AS SOON AS THE INVESTIGATION OF THE EVENT IS COMPLETED, A SUPPLEMENTAL RPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RECEIVED 50PCS 454334/B2106369 FOR EVALUATION. NO CUSTOMER PICTURES WERE RECEIVED. WE HAVE NO REMAINING INVENTORY OF THIS MATERIAL/BATCH. WE HAVE NO FURTHER COMPLAINTS FOR THIS MATERIAL/BATCH. A CHECK OF QUALITY, PRODUCTION, AND MAINTENANCE RECORDS REVEALED NO DEVIATIONS IN RELATION TO THE REPORTED EVENT. 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 NOTED. BOTH STANDARDS SPECIFY THE DRAW VOLUME TO BE WITHIN +/- 10% RANGE OF THE NOMINAL FILL VOLUME. ALL TUBES TESTED FILLED WITHIN THE +/-10% TOLERANCE RANGE. THE ALLEGED MALFUNCTION COULD NOT BE DUPLICATED. H3: SAMPLES RECEIVED; H6: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; H10: MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    CUSTOMER STATES TUBES ARE NOT PERFORMING AS THEY SHOULD AND ARE UNDERFILLING. THIS LOT NUMBER IS NOT FILLING ADEQUATELY. THEY HAVE SEVERAL TRAYS OF THE LIGHT BLUE TOP SODIUM CITRATE TUBES FOR PHLEBOTOMY FOR COAGULATION. 100% OF THE TUBES IN THIS LOT ARE EXPERIENCING THIS ISSUE. THE DEVICES BEING USED WHEN THIS IS OCCURRING IS A HUB [HOLDER] WITH ATTACHED BD COLLECTION VACUTAINER NEEDLE. WHEN A SAFETY BLOOD COLLECTION SET IS USED, A DISCARD TUBE IS DRAWN BEFORE THE COAGULATION TUBE. PHLEBOTOMISTS ARE HOLDING THE TUBE IN THE HOLDER WITH THEIR THUMB UNTIL THE TUBE IS COMPLETELY FILLED. THEY HAVE HAD MULTIPLE COMPLAINTS FROM ONSITE AND OFFSITE AND EACH COMPLAINT STATES THE SAME LOT NUMBER OF GREINER TUBES. MULTIPLE COMPLAINT FROM MULTIPLE PHLEBOTOMISTS ACROSS MULTIPLE SITES. THEY EXPIRE 6/11/22 SO THEY ARE NOT OUTDATED. THE ISSUE AND INFORMATION WAS COMMUNICATED TO THE CUSTOMER ON (B)(6). THEY DID NOT TAKE PICTURES - NO PHOTOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889520 VACUETTE® TUBE 3 ML 9NC COAGULATION SODIUM CITRATE 3,2% 13X75 EVACUATED BLOOD COLLECTION TUBES GIM GREINER BIO-ONE NA INC. 454334 B2106369

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown