BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 31GA 6MM 10BAG 500 AP

    MDR report key: 8915590 · Received August 21, 2019

    Report

    Report Number
    1920898-2019-00848
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 6, 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 · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SHELF CARTON OF 1CC, 6MM, 31G SHELF CARTONS FROM LOT # 8337913. CUSTOMER STATES THAT THERE IS A DUPLICATE LOT. THE PHOTOS WERE EXAMINED AND EXHIBITED A DOUBLE PRINTED LOT NUMBER ON THE SHELF CARTON. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8337913. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED 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. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 19AUG2019, HOLDREGE RECEIVED PHOTOS OF A CARTON FROM LOT 8337913. VISUAL INSPECTION OF THE PHOTOS FOUND DUPLICATE LOT CODE ON THE CARTON. THERE WAS SHADOW PRINT ON THE DATE CODES BUT NOT AS NOTICEABLE AS THE LOT CODING. LOT CODE IS APPLIED AT THE SCHUBERT PACKAGING MACHINE. THE MACHINE FORMS THE CARTON, PACKS THE POLYBAGS OF SYRINGES, CLOSES THE LID, AND LABELS THE LOT AND DATE CODES. IF THE MACHINE IS STOPPED OUT OF SEQUENCE DURING THE LOT CODE APPLICATION PROCESS, THE LOT CODE WOULD BE REAPPLIED ONCE THE MACHINE IS RESTARTED. REVIEW OF MAINTENANCE DISPATCHES AND QUALITY NOTIFICATIONS FOUND NO ISSUES RELATED TO THE COMPLAINT. UNABLE TO DETERMINE ROOT CAUSE OF DUPLICATE LOT CODING. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORT CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED AND TREND ON REPORTS MONITORED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML 31GA 6MM 10BAG 500 AP EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION OR ILLEGIBLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUPLICATE LOT.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1 ML 31GA 6 MM 10BAG 500 AP EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION OR ILLEGIBLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUPLICATE LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712441 SYRINGE 1ML 31GA 6MM 10BAG 500 AP SYRINGE FMF BD MEDICAL - DIABETES CARE 8337913

    Patients

    Seq Age Sex Outcome Treatment
    1 Other