BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE II NEEDLE

    MDR report key: 9696357 · Received February 11, 2020

    Report

    Report Number
    1920898-2020-00117
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 28, 2020
    Report Date
    January 30, 2020
    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 CARTON OF 1CC, 8MM, 30G SYRINGES FROM LOT # 9063822. CUSTOMER STATES THAT THE BOX IS DENTED AND HAS A DUPLICATE LOT. ALL ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED CRUSHED SHELF CARTONS WITH SOME SHELF CARTONS EXHIBITING A DOUBLE PRINTED LOT NUMBER ON THE SHELF CARTON. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063822. ALL INSPECTIONS 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. INVESTIGATION CONCLUSION: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: VISUAL INSPECTION OF THE PICTURES FOUND CARTONS THAT WERE DENTED AND TORN AT THE BACK RIGHT SEAM. THERE WERE ALSO CARTONS WITH DOUBLE PRINTED LOT INFORMATION. THE LOT NUMBER AND UP TO THE FIRST THREE DIGITS OF THE MANUFACTURING DATE WERE DOUBLE PRINTED. PROCESS SUMMARY: THE AUTOPACKOUT SYSTEM RECEIVES BAGS OF SYRINGES FROM THE FF&S MACHINE. THE EQUIPMENT ERECTS THE CARTON AND LOADS THE APPROPRIATE NUMBER 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. IF THE MACHINE IS STOPPED ABRUPTLY DURING THE APPLICATION OF THE LASER CODES; PRINTING DEFECTS CAN BE FOUND. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THESE DEFECTS. ROOT CAUSE CANNOT BE DETERMINED. 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 10 BD INSULIN SYRINGE WITH BD ULTRA-FINE II¿ NEEDLES WERE FOUND BEFORE USE WITH DUPLICATE LOTS PRINTED ON THEIR LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DENTED = 9 AND DUPLICATE LOT = 10."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160461 BD INSULIN SYRINGE WITH BD ULTRA-FINE II NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9063822

    Patients

    Seq Age Sex Outcome Treatment
    1 Other