BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 FE

    MDR report key: 8991270 · Received September 11, 2019

    Report

    Report Number
    1920898-2019-00960
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 27, 2019
    Report Date
    August 29, 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

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS OF 1CC, 12.7 MM, 29G SYRINGES FROM LOT # 8316713. CUSTOMER STATES THAT THE LOT IS MISSING AND THERE ARE DUPLICATE LOTS. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED NO LOT INFORMATION PRINTED ON THE SHELF CARTON AND DOUBLE PRINTED LOT INFORMATION ON THE SHELF CARTON. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8316713. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. ROOT CAUSE DESCRIPTION: THE AUTOPACKOUT SYSTEM RECEIVES BAGS OF SYRINGES FROM THE FF&S MACHINE. THE EQUIPMENT ERECTS THE CARTON AND LOADS THE APPROPRIATE AMOUNT OF BAGS OF SYRINGES INTO THE CARTON. THE MACHINE LASER CODES UP TO THREE LINES ON THE CARTON: LOT CODE, DATE OF MANUFACTURE, AND EXPIRATION DATE. THE CARTONS ARE CLOSED BEFORE BEING PLACED ON THE OUTFEED CONVEYOR. REVIEW OF QUALITY NOTIFICATIONS AND MAINTENANCE DISPATCHES DID NOT FIND ANY RELATED TO THIS COMPLAINT. UNABLE TO DETERMINE ROOT CAUSE OF THE AUTPACKOUT MACHINE COMING TO AN ABRUPT STOP REQUIRING A RESET. A SINGLE POINT LESSON SPL0039 FOR RESETTING THE SEQUENCE OF PACKING AFTER AN ABRUPT STOP INDICATES IN STEPS 6 & 7 TO CLEAR THE CARTONS FROM THE MACHINE TO PREVENT LOT CODING DEFECTS. 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 3 SYRINGES 1.0 ML 29GA 1/2 IN 10BAG 500 FE HAD DUPLICATE LOT NUMBERS PRINTED ON THEIR LABELS, AND 3 SYRINGES WERE MISSING THEIR LOT NUMBERS ON THEIR LABELS. ALL DEFECTS WERE FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DUPLICATE LOT = 3 MISSING LOT = 3."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786644 SYRINGE 1.0ML 29GA 1/2IN 10BAG 500 FE SYRINGE FMF BD MEDICAL - DIABETES CARE 8316713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other