BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL

    MDR report key: 10254984 · Received July 9, 2020

    Report

    Report Number
    9614033-2020-00101
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 12, 2020
    Report Date
    July 20, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION: PHOTOS RECEIVED FOR INVESTIGATION. UPON EVALUATION, ONE PHOTO OF BLISTER PACKS ARE OBSERVED WITH NO LABEL CONTENT ON THE PACKAGING. ONE PHOTO SHOWS MISSING COMPONENT INT HE PACKAGING (NEEDLE), ONLY CONTAINS A 3ML SYRINGE. POTENTIAL ROOT CAUSE FOR THE NEEDLE MISSING IS ASSOCIATED WITH THE LINE ADJUSTMENT EXECUTION. THE MULTIDISCIPLINARY TEAM HAS A VISION SYSTEM THAT HELPS DETECT THE ABSENCE OR EXCESS OF THE COMPONENTS OF THE PRODUCT, THAT IS, THE LACK OF NEEDLES OR THE PRESENCE OF TWO OR MORE NEEDLES WITHIN THE SAME PACKAGE GENERATES A SIGNAL IN THE EQUIPMENT WHICH IN AUTOMATIC STOPS THE EQUIPMENT AND SENDS A VISUAL SIGNAL OF THE PACKAGING WITH THE DEFECT. POTENTIAL ROOT CAUSE FOR LABEL CONTENT MISSING IS ASSOCIATED WITH THE LINE CLEARANCE AFTER EQUIPMENT CLEANING OR ADJUSTMENT IS NOT PERFORMED PROPERLY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL WAS MISSING THE NEEDLE ON 1300 OCCASIONS BEFORE USE. THE PRODUCT LABEL WAS MISSING ON 40 OCCASIONS AS WELL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WITHOUT NEEDLE, INSIDE THE BLISTER. DURING THE CONDITIONING PROCESS OF PREVEPOST (SIMILAR), IT WAS DETECTED IN LINE ONE PIECE OF SYRINGE WITHOUT THE NEEDLE, WHEN REVIEWING THE MATERIAL, IT WAS DETECTED 994 PIECES MORE OF SYRINGES WITHOUT NEEDLE. THE STAFF OF CONDITIONING OF PRODUCT DICLOVIT-B-FRT, WHEN PUTTING THE SYRINGE INTO THE BLISTER, DETECTED THAT THE PACKAGE OF THE SYRINGE DOES NOT CONTAIN NEEDLE, AND SOME OF THEM DON'T HAVE LABEL.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL WAS MISSING THE NEEDLE ON 1300 OCCASIONS BEFORE USE. THE PRODUCT LABEL WAS MISSING ON 40 OCCASIONS AS WELL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WITHOUT NEEDLE, INSIDE THE BLISTER. DURING THE CONDITIONING PROCESS OF PREVEPOST (SIMILAR), IT WAS DETECTED IN LINE ONE PIECE OF SYRINGE WITHOUT THE NEEDLE, WHEN REVIEWING THE MATERIAL, IT WAS DETECTED 994 PIECES MORE OF SYRINGES WITHOUT NEEDLE. THE STAFF OF CONDITIONING OF PRODUCT DICLOVIT-B-FRT, WHEN PUTTING THE SYRINGE INTO THE BLISTER, DETECTED THAT THE PACKAGE OF THE SYRINGE DOES NOT CONTAIN NEEDLE, AND SOME OF THEM DON'T HAVE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720042 SYR 3ML 22GA 1-1/4IN JPK/SIL NO ASSY NDL SYRINGE FMF BECTON DICKINSON DE MEXICO 9325575

    Patients

    Seq Age Sex Outcome Treatment
    1 Other