BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II INSULIN SYRINGE

    MDR report key: 8356014 · Received February 20, 2019

    Report

    Report Number
    1920898-2019-00194
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    February 11, 2019
    Report Date
    February 13, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS OF 1/2CC, 8MM, 30G SYRINGES FROM LOT # 8113627. CUSTOMER STATES THAT THERE IS A DUPLICATE LOT. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED A DOUBLE PRINTED LOT NUMBER ON THE SHELF CARTONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113617. 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. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: PROBABLE ROOT CAUSE SUGGESTS THAT THE SINGLE SHELF CARTON WAS PASSED THROUGH THE LASER ETCHING STATION TWICE. DURING ROUTINE PRODUCTION, WHEN A JAM OCCURS ON THIS LINE, THE OPERATOR SHOULD CLEAR THE JAM AND ANY CARTON PAST THE LASER ETCHING STATION MUST BE MANUALLY PLACED BACK IN THE LINE. IF THIS IS PLACED PRIOR TO THE ETCHING STATION, A DOUBLE PRINT CAN OCCUR, AS IN THIS INSTANCE. 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 THE BD ULTRA-FINE¿ II INSULIN SYRINGE PACKAGING HAD A "DUPLICATE LOT" PRINTING ERROR ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149635 BD ULTRA-FINE II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8113627

    Patients

    Seq Age Sex Outcome Treatment
    1 Other