BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE

    MDR report key: 6150881 · Received December 7, 2016

    Report

    Report Number
    3003902955-2016-00042
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    PMA / PMN Number
    K051865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - NOT APPLICABLE SINCE THE LOT NUMBER IS UNKNOWN. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. SINCE PRODUCT LOT NUMBER IS UNKNOWN, OUR INVESTIGATION IS LIMITED AND A REVIEW OF PRODUCTION OR COMPLAINT RECORDS WAS NOT POSSIBLE. VISUAL, SENSORY AND FUNCTIONAL TESTING IS CONDUCTED TO ASSURE ALL ASSEMBLED SG2 NEEDLES MEET MANUFACTURER SPECIFICATIONS. PRIOR SHIPMENT, QC CONDUCTS OUTGOING INSPECTIONS AND TESTING TO ASSURE ALL LOTS PASS. BASED ON THE LIMITED PRODUCT INFORMATION PROVIDED, NO PROBABLE ROOT CAUSE COULD BE DETERMINED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955. EXEMPTION NUMBER E2015017. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR TRACKING, TRENDING, AND FOLLOW UP. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM THE (B)(4) REPRESENTATIVE THAT " THIS CUSTOMER ORDERS A TON OF THIS PRODUCT FROM US AND THEY HAVEN'T HAD ANY ISSUES, BUT IN THE LAST FEW MONTHS THEY HAVE HAD SIX NEEDLE STICKS WITH THIS PRODUCT". SEE MDRS 3003902955-2016-00041, 3003902955-2016-00043, 3003902955-2016-00044, 3003902955-2016-00045 & 3003902955-2016-00046 FOR THE OTHER FIVE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802083 MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE SYRINGE, ANTISTICK MEG TERUMO PHILIPPINES CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1