BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SLIP TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 16261485 · Received January 28, 2023

    Report

    Report Number
    8041187-2023-00036
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    January 10, 2023
    Report Date
    March 10, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE BLACK DUST FOREIGN MATTER INSIDE THE PACKAGE AND SYRINGE COULD BE DUE TO PEST INFESTATION. THE FOREIGN MATTER COULD HAVE BEEN BROUGHT INTO THE PACKAGE WHEN THE PEST BIT THE BOTTOM WEB TO ENTER THE PACKAGING. THE PRODUCT COULD HAVE BEEN INFESTED WITH PEST DUE TO UNCONTROLLED STORAGE CONDITIONS BEFORE DISTRIBUTED TO THE CUSTOMERS¿ PREMISES. THE NON-CONFORMANCE COULD HAVE OCCURRED OUT OF THE MANUFACTURING FACILITY. THE TEAM HAD ALSO REVIEWED THE PEST CONTROLS RECORDS AND NO ABNORMALITIES WERE DETECTED AT THE 1ML MANUFACTURING LINE. HENCE, WE ARE UNABLE TO IDENTIFY THE ROOT CAUSE OF THE REPORTED NON-CONFORMANCE. DHR FOR SYRINGE WAS PERFORMED FOR THE BATCH 2140745 H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD SLIP TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE OPENING NEW SYRINGE NURSE OBSERVED FOREIGN MATERIAL INSIDE SYRINGE BARREL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SLIP TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE HAD FOREIGN MATTER IN THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE OPENING NEW SYRINGE NURSE OBSERVED FOREIGN MATERIAL INSIDE SYRINGE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380809 BD SLIP TIP SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 2140745

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown