BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE¿ MANUAL NEEDLE GUARD B100L

    MDR report key: 7186982 · Received January 12, 2018

    Report

    Report Number
    3009081593-2017-00041
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    December 20, 2017
    Report Date
    March 9, 2018
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    PMA / PMN Number
    K972878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A BROKEN NEEDLE GUARD 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. THIS DEVICE WAS DESIGNED WITH A LOW CLIPPING FORCE TO ACCOMMODATE EASILY ALL TYPES OF SYRINGES DURING DEVICE ASSEMBLY AND SO MINIMIZING RISK OF FLANGE OR DEVICE BREAKAGE. THE DRAW-BACK OF THIS DESIGN IS THE RELATIVELY LOW RETENTION FORCE. BASED ON INVESTIGATION CONCLUSION THE SYRINGE MOST LIKELY BECAME DETACHED AS IT WAS NOT CLIPPED INTO THE DEVICE OR THE PRODUCT RECEIVED AN EXTERNAL IMPACT AFTER SYRINGE INSERTION WHICH CAUSED THE SYRINGE TO UNCLIP FROM THE DEVICE. INVESTIGATION CONCLUSION: THIS PRODUCT WAS DESIGNED WITH A LOW CLIPPING FORCE TO ACCOMMODATE EASILY ALL TYPES OF SYRINGES DURING DEVICE ASSEMBLY AND SO MINIMIZING RISK OF FLANGE OR DEVICE BREAKAGE. THE DRAW-BACK OF THIS DESIGN IS THE RELATIVELY LOW RETENTION FORCE. BASED ON INVESTIGATION CONCLUSION A SYRINGE CAN ONLY BECOME DETACHED IF SYRINGE CAPTURE FEATURES (HOLDING CLIPS) OF THE DEVICE OR THE FLANGE OF THE SYRINGE GET DAMAGED/BROKEN OR THE SYRINGE RECEIVES AN IMPACT AFTER SYRINGE INSERTION WHICH CAUSES IT TO UNCLIP FROM THE DEVICE. THE MANUAL NEEDLE GUARDS SYRINGE FLANGE HOLDING CLIPS WERE OBSERVED STRAIGHT AND PROPERLY ALIGNED. THE SYRINGE FLANGE AND BARREL WERE NOT CRACKED OR BROKEN. BASED ON THE DEFORMATION SEEN ON ONE OF THE HOLDING CLIPS THE SYRINGE WAS UNCLIPPED FROM THE DEVICE. THEREFORE, THE SYRINGE MOST LIKELY BECAME DETACHED AS IT RECEIVED AN EXTERNAL IMPACT AFTER SYRINGE INSERTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6031334; MEDICAL DEVICE EXPIRATION DATE: 01/31/2020; DEVICE MANUFACTURE DATE: 01/31/2016. MEDICAL DEVICE LOT #: 5295223; MEDICAL DEVICE EXPIRATION DATE: 09/30/2019; DEVICE MANUFACTURE DATE: "10/22/215." A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD ULTRASAFE¿ MANUAL NEEDLE GUARD B100L WHEN THE NURSE OPENED THE INTERNAL CONTAINER, SHE NOTICED THE GUARD WAS LOOSE ON THE SYRINGE. NEEDLE GUARD WAS BROKEN AND COMPLETELY SEPARATED FROM THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31514 BD ULTRASAFE¿ MANUAL NEEDLE GUARD B100L SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other