BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE 0.5 ML

    MDR report key: 9720226 · Received February 18, 2020

    Report

    Report Number
    1920898-2020-00141
    Event Type
    Malfunction
    Date Received
    February 18, 2020
    Date of Event
    January 29, 2020
    Report Date
    March 4, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : CUSTOMER RETURNED (1) LOOSE 1/2CC BD SAFETYGLIDE INSULIN SYRINGE WITHOUT ANY PACKAGING. CUSTOMER STATES THAT THE CHAMBER WHERE INSULIN IS HELD ONCE IT IS DRAWN INTO VIAL IS BROKEN. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A PIECE OF THE BARREL BROKEN OFF RANGING FROM THE 0-20 UNIT MARKING. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231522. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. A REVIEW OF THE PHOTO FOUND A SYRINGE WITH A BROKEN BARREL FROM THE ZERO LINE TO THE 20-SCALE UNIT MARKING. THE SAFETY MECHANISM WAS DETACHED FROM THE BARREL. THE BARREL IS NOT BOWED NOR DOES THE BARREL AND/OR PLUNGER DISPLAY ANY DAMAGE. FROM THIS VISUAL INSPECTION THE DAMAGE MAY HAVE OCCURRED AT THE PRINTER OPERATION. PROCESS SUMMARY: BLANK BARRELS ARE TRANSFERRED FROM TOTES TO A BULK HOPPER, THE HOPPER THEN TRANSPORTS 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: NONE/CANNOT BE DETERMINED INVESTIGATION: A VISUAL INSPECTION IS PERFORMED EVERY HALF HOUR FOR PRINT AND BARREL COMPONENT DEFECTS. NO DOCUMENTED FAILURES (CRACKED BARRELS) AT THE INSPECTION DIAL NO DOCUMENTED FAILURES (CRACKED BARRELS) AT THE INHABIT GATE. NO DOCUMENTED FAILURES (CRACKED BARRELS) AT THE INFEED DIAL TRANSITION. NO DOCUMENTED FAILURES (CRACKED BARRELS) AT THE TRANSFER DIAL TO OVEN OR DIAL OVEN. THERE ARE NO L2L DISPATCHES, LOGBOOK ENTRIES OR NOTIFICATIONS FOR MISSING COMPONENTS FROM THE TIME THAT THIS BATCH WAS PRODUCED CAPA # 1187550 WAS OPENED TO ADDRESS THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5 ML WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328447 BATCH NO: 9231522. IT WAS REPORTED THAT THE CHAMBER WHERE INSULIN IS HELD ONCE IT IS DRAWN INTO VIAL IS BROKEN (INSIDE SYRINGE IS EXPOSED). VERBATIM: CHAMBER WHERE INSULIN IS HELD ONCE IT IS DRAWN INTO VIAL IS BROKEN (INSIDE SYRINGE IS EXPOSED). RN WHO REPORTED THIS PRODUCT DEFECT MENTIONED THAT THIS IS HOW THE SYRINGE CAME IN THE PACKAGE. THERE WAS NO SHARES OF PLASTIC IN THE PACKAGING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5 ML WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328447 BATCH NO: 9231522. IT WAS REPORTED THAT THE CHAMBER WHERE INSULIN IS HELD ONCE IT IS DRAWN INTO VIAL IS BROKEN (INSIDE SYRINGE IS EXPOSED). VERBATIM: CHAMBER WHERE INSULIN IS HELD ONCE IT IS DRAWN INTO VIAL IS BROKEN (INSIDE SYRINGE IS EXPOSED). RN WHO REPORTED THIS PRODUCT DEFECT MENTIONED THAT THIS IS HOW THE SYRINGE CAME IN THE PACKAGE. THERE WAS NO SHARES OF PLASTIC IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187494 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE 0.5 ML SYRINGE, ANTISTICK MEG BD MEDICAL - DIABETES CARE 9231522

    Patients

    Seq Age Sex Outcome Treatment
    1 Other