BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE - X100L

    MDR report key: 8802612 · Received July 18, 2019

    Report

    Report Number
    3009081593-2019-00171
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    April 25, 2019
    Report Date
    July 18, 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
    IS
    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 #: 6116148, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31, DEVICE MANUFACTURE DATE: 2016-04-25. MEDICAL DEVICE LOT #: 7187089, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2017-07-06. MEDICAL DEVICE LOT #: 7138317, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2017-05-18. 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 PRE-ACTIVATED DEVICE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO 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: 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. DURING THE YEARS OF INVESTIGATION OF COMPLAINTS ABOUT PRE-ACTIVATED DEVICES SEVERAL ROOT CAUSES WERE DISCOVERED WHICH WERE WITHIN THE CUSTOMER¿S SPHERE OF INFLUENCE. BEST PRACTICES AND GUIDELINES WERE COLLECTED AND SUMMARIZED IN (B)(4). ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. 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 1 BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE - X100L FROM LOT# 6116148 HAD A PREACTIVATED SAFETY SHIELD BEFORE USE. LOTS 7187089 AND 7138317 WERE ALSO REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNCLEAR HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRE ACTIVATIOV SAFETY DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599093 BD ULTRASAFE PASSIVE X-SERIES NEEDLE GUARD SYRINGE - X100L PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other