BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12788096 · Received November 10, 2021

    Report

    Report Number
    9614033-2021-00133
    Event Type
    Malfunction
    Date Received
    November 10, 2021
    Date of Event
    October 13, 2021
    Report Date
    November 24, 2021
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMI. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: PHOTOS RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION AN ASSEMBLED NEEDLE WITH A MISSING COMPONENT (SHIELD) WHICH COMES OUT OF THE BLISTER IN ITS UPPER PART, THAT IS, ABOVE THE PIVOT, IS OBSERVED. THIS PRODUCT HAS THE NEEDLE ASSEMBLED ON ONE SIDE AND ANOTHER ONE ABOVE THE PIVOT OF THE BARREL, FOR WHICH THE PRESENCE OF A DOUBLE COMPONENT IS DETECTED, ANOTHER OF THE SYRINGES HAS A DOUBLE COMPONENT BUT THIS SECOND NEEDLE IS INSIDE THE BLISTER IN THE SAME WAY WITHOUT A SHIELD. 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. POSSIBLE ROOT CAUSE FOR MULTIPLE COMPONENTS IN PACKAGE AND SHIELD MISSING IS ASSOCIATED WITH THE NEEDLE FEEDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD 3ML SYRINGE 22GA 1-1/4IN JPK/SIL NO ASSY NDL WHERE THE STERILITY OF PRODUCT WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING THE INSPECTION OF THIS BATCH ONE OF THEM WAS EXPOSED AND WITHOUT A CAP THAT COULD HAVE CAUSED AN INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD 3ML SYRINGE 22GA 1-1/4IN JPK/SIL NO ASSY NDL WHERE THE STERILITY OF PRODUCT WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: DURING THE INSPECTION OF THIS BATCH ONE OF THEM WAS EXPOSED AND WITHOUT A CAP THAT COULD HAVE CAUSED AN INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688435 BD 3ML SYRINGE 22GA 1-1/4IN JPK/SIL NO ASSY NDL PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 1197373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown