BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7629386 · Received June 22, 2018

    Report

    Report Number
    1920898-2018-00447
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    June 3, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PARTIALLY CRUSHED (1) 1CC 31G 6MM RELION SYRINGE IN AN OPEN POLYBAG FROM LOT NUMBER 7093923. SEE ATTACHED PHOTO. CUSTOMER STATES THAT WHEN TAKING THE SYRINGE OUT OF THE PACKAGE A NEEDLE STICK OCCURRED AND NOTICED THE NEEDLE WAS BENT. THE RETURNED SYRINGE WAS EXAMINED AND IT WAS OBSERVED TO HAVE NO SHIELD AND THE CANNULA WAS BENT, WHICH EXPOSES THE CANNULA AND COULD CAUSE A NEEDLE STICK. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7093923. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200693944] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: POSSIBLE ROOT CAUSES: 1.DEFECT COULD HAVE OCCURRED AT THE PREP DIAL OF THE METRO ASSEMBLY MACHINE LOSS OF BACK PRESSURE ON THE IN-FEED RAIL MAY CAUSE THE BARREL TO BECOME PINCHED AT THE RAIL / PREP DIAL JUNCTION. THE TRIP GATE EYE SENSOR SHOULD DETECT LOW RAIL CONDITIONS AND ACTIVATE THE TRIP GATE TO PREVENT THE BARRELS FROM BEING LOADED INTO THE PREP DIAL AND POSSIBLY JAMMING AT THAT LOCATION. 2.INFEED DIAL AT BARREL PRINTERS. 3.LOSS OF BACK PRESSURE AT INFEED RAIL ALSO AT FORM FILL & SEAL.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS FOUND WITH PACKAGE INTEGRITY. CONSUMER ALSO STATES THAT THE SHIELD WAS MISSING FROM THE SYRINGE. THERE WAS NO REPORT OF MEDICAL INTERVENTION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS FOUND WITH PACKAGE INTEGRITY. CONSUMER ALSO STATES THAT THE SHIELD WAS MISSING FROM THE SYRINGE. THERE WAS NO REPORT OF MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    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 THAT BEFORE USE A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS FOUND WITH PACKAGE INTEGRITY. CONSUMER ALSO STATES THAT THE SHIELD WAS MISSING FROM THE SYRINGE. THERE WAS NO REPORT OF MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474456 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7093923

    Patients

    Seq Age Sex Outcome Treatment
    1 Other