BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCHRON JR. DIRECTCHECK CITRATE PT ABNORMAL

    MDR report key: 6142730 · Received December 2, 2016

    Report

    Report Number
    3002721930-2016-00016
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 25, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ACCRIVA DIAGNOSTICS
    Product Code
    GGN
    PMA / PMN Number
    K944691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR SUBMITTED ON (B)(6) 2016 REFERENCES ACCRIVA DIAGNOSTICS' COMPLAINT NUMBER (B)(4). ACTUAL DEVICE NOT EVALUATED. NO DHR REVIEW WAS REQUIRED BECAUSE THE COMPLAINT IS UNRELATED TO PRODUCT PERFORMANCE OR PACKAGING. (B)(4). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. (B)(4). HUMAN FACTORS ISSUE. TRAINING DEFICIENCY. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN END USER SUSTAINED A LACERATION WHILE DISPENSING A DIRECTCHECK QUALITY CONTROL FOR A HEMOCHRON SIGNATURE ELITE AND CITRATE PT MICROCOAGULATION SYSTEM. THIS CONTROL IS PACKAGED IN A GLASS AMPULE CONTAINED WITHIN A CRUSHABLE PLASTIC DROPPER VIAL CONTAINING DILUENT. THE END-USER WAS WEARING GLOVES AND WAS USING THE PROTECTIVE SLEEVE PROVIDED WITH THE PRODUCT WHEN RECONSTITUTING THE CONTROL. SHE REMOVED THE PROTECTIVE SLEEVE, SQUEEZED THE VIAL TO DISPENSE THE CONTROL AND A GLASS SHARD PROTRUDED THROUGH THE DROPPER VIAL PIERCING THE SKIN OF HER RIGHT INDEX FINGER. MINOR BLEEDING OCCURRED. THE END USER WASHED HER HAND WITH SOAP AND WATER AND APPLIED A BANDAID TO THE INJURED AREA. NO SIGNIFICANT BLOOD LOSS OR OTHER MEDICAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792758 HEMOCHRON JR. DIRECTCHECK CITRATE PT ABNORMAL PLASMA, COAGULATION CONTROL GGN ACCRIVA DIAGNOSTICS DCJCPT-A H6DAC007

    Patients

    Seq Age Sex Outcome Treatment
    1