BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 10900079 · Received November 25, 2020

    Report

    Report Number
    1917413-2020-01183
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 23, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678445
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES EXPERIENCED TUBE EXTENDERS WITH MOLDING DEFECTS THAT CAN BE USED (LARGE INDENTATION IN TUBE WALL). THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "TUBES ARE DEFORMED. THEY FOUND 2 MORE DEFECTIVE TUBES TODAY, THESE HAD THE CONVENTIONAL CAPS. PRODUCT #367844, LOT#0133329. THE FLAW IS DOWN THE SIDE WALL OF THE TUBE. WE ARE ONLY SEEING THE ONES THAT OUR INSTRUMENT REJECTS WHEN THE PROBE HITS THE PLASTIC PROJECTING FROM THE WALL OF THE TUBE. THERE MAYBE MORE THE INSTRUMENT IS NOT REJECTING."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES EXPERIENCED TUBE EXTENDERS WITH MOLDING DEFECTS THAT CAN BE USED (LARGE INDENTATION IN TUBE WALL). THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED "TUBES ARE DEFORMED. THEY FOUND 2 MORE DEFECTIVE TUBES TODAY, THESE HAD THE CONVENTIONAL CAPS. PRODUCT #367844 LOT#0133329. THE FLAW IS DOWN THE SIDE WALL OF THE TUBE. WE ARE ONLY SEEING THE ONES THAT OUR INSTRUMENT REJECTS WHEN THE PROBE HITS THE PLASTIC PROJECTING FROM THE WALL OF THE TUBE. THERE MAYBE MORE THE INSTRUMENT IS NOT REJECTING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366806 BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367844 0133329 50382903678445

    Patients

    Seq Age Sex Outcome Treatment
    1