BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG RASPBERRY NVS STEIN

    MDR report key: 9310246 · Received November 12, 2019

    Report

    Report Number
    3009081593-2019-00248
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 4, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8071890, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-03-12. MEDICAL DEVICE LOT #: 8068790, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2018-03-09. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K011369, PMA / 510(K)#: K122558. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A DETACHED DEVICE DETECTED BY END USER. NEITHER PHOTO NOR SAMPLE WAS 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 MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: BASED ON INVESTIGATION CONCLUSION A SYRINGE CAN ONLY BECOME DETACHED IF SYRINGE CAPTURE FEATURES OR THE FLANGE OF THE SYRINGE GET DAMAGED/BROKEN OR IF THE SYRINGE RECEIVES AN IMPACT AFTER SYRINGE INSERTION WHICH CAUSES IT TO UNCLIP FROM THE DEVICE. THEREFORE, THE SYRINGE MOST LIKELY BECAME DETACHED AS IT WAS NOT CLIPPED INTO THE DEVICE PROPERLY OR IT RECEIVED AN EXTERNAL IMPACT AFTER SYRINGE INSERTION WHICH CAUSED IT TO UNCLIP FROM THE DEVICE. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASAFE X100L PNG RASPBERRY NVS STEIN SEPARATED FROM THE PLASTIC CASING BEFORE USE, AND WAS FOUND AFTER OPENING UP THE PACKAGING. WHEN ATTEMPTING TO REASSEMBLE THE DEVICE, THE SAFETY MECHANISM ENGAGED. LOT# 8071890 WAS REPORTED TO HAVE 1 OCCURRENCE OF THE EVENT, WHILE LOT# 8068790 WAS REPORTED TO HAVE AN UNSPECIFIED NUMBER OF OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONTACT IN ROW 1 REPORTED WHEN NURSE OPENED THE XOLAIR PFS PACKAGE, THE SYRINGE WAS SEPARATED FROM THE PURPLE COLORED PLASTIC CASING AND WHEN THE RN TRIED TO REASSEMBLE, THE SAFETY NEEDLE DEVICE ENGAGED"; LOOSE NEEDLE SAFETY DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103451 ULTRASAFE X100L PNG RASPBERRY NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other