BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD BBL¿ BIO-BAG¿ ENVIRONMENTAL CHAMBER TYPE CFJ

    MDR report key: 7679811 · Received July 11, 2018

    Report

    Report Number
    9610847-2018-00222
    Event Type
    Injury
    Date Received
    July 11, 2018
    Date of Event
    June 18, 2018
    Report Date
    August 30, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    KZJ
    UDI-DI
    00382902612124
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: REQUIRED INTERVENTION. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD BBL BIO-BAG ENVIRONMENTAL CHAMBER TYPE CFJ A LAB ASSISTANT WAS CUT THROUGH THEIR GLOVE ATTEMPTING TO CRUSH THE GLASS AMPOULE. THE LAB ASSISTANT RECEIVED MEDICAL INTERVENTION AT AN EMERGENCY ROOM FOLLOWING THE INCIDENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INVESTIGATION SUMMARY: AFTER REVIEWING THE DHR NO INTERNAL REJECTS RELATED TO BROKEN/DAMAGED WAS FOUND DURING MANUFACTURING PROCESS. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST COMPLAINT REPORTED FOR THE INJURY (BROKEN / DAMAGED) ON LOT NUMBER 7156506 AND IS THE 1ST COMPLAINT RECEIVED WITH THIS TYPE OF DEFECT ON THE LAST 12 MONTHS RELATED TO CATALOG 261212. INVESTIGATION CONCLUSION: DUE TO NO SAMPLES TO EVALUATE WERE RECEIVED IT WAS NOT POSSIBLE TO DETERMINATE IF THE PRODUCT MANUFACTURE COULD CONTRIBUTE TO THE REPORTED FAILURE. HOWEVER BASED ON THE PRODUCT DESIGN IS VERY UNLIKELY TO HAVE THIS KIND OF SITUATIONS SINCE THE AMPOULE IN THE GENERATOR NEEDS TO PERFORATE THE FOLLOWING COMPONENTS (TUBE, SLEEVE, LABEL & ANAEROBIC BAG) BEFORE INJURY TO THE CUSTOMERS. ROOT CAUSE DESCRIPTION: BASED ON THE NATURE OF THE REPORTED DEFECT WITHOUT SAMPLE AND/OR ANY PICTURE OF THE FAILED PRODUCT THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD BBL¿ BIO-BAG¿ ENVIRONMENTAL CHAMBER TYPE CFJ A LAB ASSISTANT WAS CUT THROUGH THEIR GLOVE ATTEMPTING TO CRUSH THE GLASS AMPOULE. THE LAB ASSISTANT RECEIVED MEDICAL INTERVENTION AT AN EMERGENCY ROOM FOLLOWING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521813 BD BBL¿ BIO-BAG¿ ENVIRONMENTAL CHAMBER TYPE CFJ GAS-GENERATING DEVICE KZJ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7156506 00382902612124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention