BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR PFE PUURS

    MDR report key: 10659663 · Received October 9, 2020

    Report

    Report Number
    3001741852-2020-00038
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    March 28, 2019
    Report Date
    November 30, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR ULTRASAFE DEVICES WHICH DID NOT ACTIVATE DETECTED DURING USE IN THE MARKET. NO SAMPLES WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S) AND WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. WITH NO SAMPLES PROVIDED, IT HAS NOT BEEN POSSIBLE TO IDENTIFY A ROOT CAUSE FOR THIS COMPLAINT H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE USER WAS UNABLE TO ACTIVATE ULTRASAFE X100L PNG CLEAR PFE PUURS SAFETY MECHANISM. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN LET ME KNOW TWO PATIENTS HAD REPORTED PROBLEMS FROM MALFUNCTIONING PLUNGERS. THE PLUNGERS WEREN¿T FULLY ACTIVATING THE SAFETY MECHANISM, AND IT¿S NOT KNOWN IF ALL THE MEDICATION WAS BEING ADEQUATELY ADMINISTERED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7335879, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: (B)(6) 2017. MEDICAL DEVICE LOT #: 7341504 MEDICAL DEVICE EXPIRATION DATE: 2021-11-30 DEVICE MANUFACTURE DATE: (B)(6) 2017 THE CUSTOMER'S ADDRESS IS (B)(6) HAS BEEN USED AS A DEFAULT. 510(K)#: (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER WAS UNABLE TO ACTIVATE ULTRASAFE X100L PNG CLEAR PFE PUURS SAFETY MECHANISM. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN LET ME KNOW TWO PATIENTS HAD REPORTED PROBLEMS FROM MALFUNCTIONING PLUNGERS. THE PLUNGERS WEREN¿T FULLY ACTIVATING THE SAFETY MECHANISM, AND IT¿S NOT KNOWN IF ALL THE MEDICATION WAS BEING ADEQUATELY ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124118 ULTRASAFE X100L PNG CLEAR PFE PUURS PISTON SYRINGE MEG BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other