BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR NVS STEIN

    MDR report key: 10305639 · Received July 21, 2020

    Report

    Report Number
    3009081593-2020-00071
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    May 13, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A DETACHED DEVICE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS DID NOT PERFORM A BATCH HISTORY RECORD¿S REVIEW (BHR) BASED ON THE FACTS THAT BATCH RECORD DOES NOT EXTEND TO SYRINGE PRODUCTION AND QUALITY RESULT OVERVIEW IN CASE OF SYRINGE PRODUCTION IS NOT SCOPE BD TATABÁNYA PRODUCTION PROCESS. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ULTRASAFE X100L PNG CLEAR NVS STEIN WAS NOT SECURE ON THE SYRINGE AND SEPARATED FROM IT, SMASHING ONTO THE FLOOR WITH THE LIQUID INSIDE. THIS OCCURRED 2 TIMES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT REPORTED THAT WHEN HE TOOK HIS SYRINGE OUT THE BOX THE INNER BIT WAS NOT SECURE WITH THE OUTER BIT AND AS A RESULT WHEN THE INJECTION WAS TAKEN OUT THE HALF WITH THE LIQUID FELL ON THE FLOOR AND SMASHED. PT THEN TOOK THE OTHER INJECTION OUT THE BOX TO USE INSTEAD AND HAD THE SAME ISSUE WITH THIS WHERE THE INNER AND OUTER BIT WERE NOT INTACT HOWEVER PATIENT MANAGED TO CLIP THIS BACK TOGETHER AND SUCCESSFULLY USED THE SYRINGE.¿¿

    Additional Manufacturer Narrative · 1

    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. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASAFE X100L PNG CLEAR NVS STEIN WAS NOT SECURE ON THE SYRINGE AND SEPARATED FROM IT, SMASHING ONTO THE FLOOR WITH THE LIQUID INSIDE. THIS OCCURRED 2 TIMES BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PT REPORTED THAT WHEN HE TOOK HIS SYRINGE OUT THE BOX THE INNER BIT WAS NOT SECURE WITH THE OUTER BIT AND AS A RESULT WHEN THE INJECTION WAS TAKEN OUT THE HALF WITH THE LIQUID FELL ON THE FLOOR AND SMASHED. PT THEN TOOK THE OTHER INJECTION OUT THE BOX TO USE INSTEAD AND HAD THE SAME ISSUE WITH THIS WHERE THE INNER AND OUTER BIT WERE NOT INTACT HOWEVER PATIENT MANAGED TO CLIP THIS BACK TOGETHER AND SUCCESSFULLY USED THE SYRINGE.¿¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770139 ULTRASAFE X100L PNG CLEAR NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 9059604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other