BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 30GA 8MM

    MDR report key: 10048363 · Received May 12, 2020

    Report

    Report Number
    1920898-2020-00506
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 29, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR LABEL INFORMATION MISSING (NO LOT) ON LOT # 9231286. CUSTOMER RETURNED PHOTOS OF SHELF CARTON FOR 1/2CC, 8MM, 30G SYRINGES FROM LOT # 9231286. CUSTOMER STATES THAT THERE IS NO LOT. THE PHOTOS WERE EXAMINED AND EXHIBITED NO LOT NUMBER, MANUFACTURING DATE, OR EXPIRATION DATE INFORMATION PRINTED ON THE SHELF CARTON. MANUFACTURING ((B)(4)) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231286. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. 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. 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: ON 01 MAY 2020, (B)(4) RECEIVED PHOTOS COMPLAINT FOR MISSING SHIPPING CARTON LABEL. VISUAL INSPECTION OF THE PICTURES SHOWS A SHIPPER FROM LOT # 9231286 THAT IS MISSING LOT CODING ON CARTON. THERE IS SOME TEARING OF THE CARDBOARD ON THE TOP OF THE BOX. PROCESS SUMMARY: THE EQUIPMENT ERECTS CARTONS AND AN ASSOCIATE PLACE THE APPROPRIATE NUMBER OF BAGS INTO THE CARTON. THE CARTONS ARE THEN CLOSED AND PLACED ON THE OUT FEED CONVEYOR. THE LOT CODING IS LASER ETCHED ONTO THE CARTON THE TRANSFERRED TO THE CASE PACK WHERE 5 CARTONS ARE PUSHED INTO A WRAPAROUND CASE. THIS CASE IS THEN GLUED AND CONTINUES TO BE LABELLED AND PALLETIZED. A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOT INFORMATION WAS MISSING ON 4 BOXES AND DISCOVERED PRIOR TO USE WITH A BD SYRINGE 0.5ML 30GA 8MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509999 BD SYRINGE 0.5ML 30GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other