BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE INSULIN SYRINGE NEEDLE

    MDR report key: 10059534 · Received May 14, 2020

    Report

    Report Number
    1920898-2020-00519
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 24, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382904826017
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTO OF 3/10CC SYRINGES. CUSTOMER STATES THAT THE SCALING IS INCORRECT AND THE CANNULA IS DIRTY. THE PHOTOS WERE EXAMINED AND EXHIBITED DARK MATERIAL EITHER ON OR EMBEDDED IN THE BARREL. ALSO, IT IS DIFFICULT TO DETERMINE IF THE SCALE MARKING PLACEMENTS FALL OUT OF SPECIFICATIONS SOLELY. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9042899. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200810276, 200810223] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (FM). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SCALE MISALIGNED). ROOT CAUSE DESCRIPTION: "ON 05 MAY 2020, (B)(4) RECEIVED PHOTOS OF A COMPLAINT FOR FM IN SYRINGE. VISUAL INSPECTION OF THE PICTURE SHOWS BROWN LIKE FM ON THE TIP OF A SYRINGE. PROCESS SUMMARY: BLANK BARRELS ARE TRANSFERRED FROM TOTES TO A BULK HOPPER, THE HOPPER THEN METERS THEM INTO THE VIBRATORY FEEDER WHICH ORIENTS AND TRANSFERS THE BARRELS SINGLE FILE INTO THE FIRST INLINE FEEDER. THE FIRST INLINE FEEDER RAIL TRANSFERS TO THE INSPECTION DIAL WHERE SHORT MOLDING DEFECTS ARE REJECTED. AFTER THE INSPECTION DIAL, THE BARRELS ARE TRANSFERRED TO THE SECOND INLINE FEEDER AND TRANSITIONS THROUGH THE CORONA TREATER TERMINATING AT THE INHIBIT GATE. AT CYCLE START, THE INHIBIT GATE OPENS, INTRODUCING BARRELS TO PRINTER INFEED DIAL ON THROUGH THE FLANGE GUIDE WHICH ALIGNS THE FLANGES FOR PROPER REGISTRATION AND INTO THE PRINT CAROUSEL WHERE INK IMAGES ARE APPLIED. FROM THE PRINT CAROUSEL, THE BARRELS ARE TRANSITIONED TO THE TRANSFER DIAL AND INTO THE CURING OVEN. THE CURED PRODUCT EXITS THE OVEN CHUTE FOR TRANSFER TO THE NEXT OPERATION. ROOT CAUSE: EXCESS GREASE ON CHAIN. L2L DISPATCH #59732 WAS CREATED. CORRECTION: THE CHAIN WAS CLEANED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER AND SCALE MARKING ERROR WERE FOUND DURING USE WITH A BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SCALING INCORRECT+CANNULA IS DIRTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518515 BD MICRO-FINE INSULIN SYRINGE NEEDLE SYRINGE FMF BD MEDICAL - DIABETES CARE 9042899 00382904826017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other