BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LS 24X1 DN

    MDR report key: 13119716 · Received December 30, 2021

    Report

    Report Number
    2243072-2021-03008
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 4, 2021
    Report Date
    January 13, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/7/2021. H.6. INVESTIGATION: THE SAMPLES WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE RETURNED SAMPLE OF (3) EMERALD 5ML FROM LOT # 1030357 PRODUCT # 303080 WITH THE REPORTED ISSUE THAT ¿CLEARLY VISIBLE FOREIGN PARTICLES / STOPPER'S DRY ARTICLES INSIDE THE SEALED PACK¿. THE DHR OF MATERIAL NUMBER 303080 AND LOT NUMBER 1030357 WAS CHECKED AND NO QUALITY NOTIFICATION WAS RECORDED ON THIS LOT. THREE SAMPLES AND THREE PHOTOGRAPHS WERE RECEIVED FROM THE CUSTOMER AND WERE USED FOR INVESTIGATION OF THE REPORTED DEFECT. NONE OF THE TEN RETENTION SAMPLES SHOWED ANY FOREIGN MATTER IN THEM. THE PHOTOGRAPHS OF THE COMPLAINT SAMPLE VISIBLY SHOW FOREIGN MATTER. THE DEFECT IS CONFIRMED. 1. WHY WAS THERE FOREIGN MATTER INSIDE THE SYRINGE STOPPER? THE SYRINGE STOPPER AREA WAS FOUND TO HAVE HOLES EXACTLY AT THE PLACES WERE THE FOREIGN MATTER IS FOUND TO HAVE GOT ACCUMULATED. 2.WHY WERE THERE HOLES ON THE PACKED UNOPENED SYRINGE PACKAGES? THE HOLES COULD HAVE GOT CREATED DUE TO PEST INFESTATION. 3.WHY WAS THERE PEST INFESTATION? UNHEALTHY OR UNHYGIENIC STORAGE CONDITIONS COULD HAVE LED TO PEST INFESTATION 4. WHY WAS THE FACILITY UNHYGIENIC? THIS COULD HAVE TAKEN PLACE AT THE SUPER STOCKIEST LEVEL. THERE IS NO CONTROL OVER THE SUPER STOCKIEST WAREHOUSES OR THEIR STORAGE AREA. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    (B)(4). (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 · 0

    IT WAS REPORTED THAT 100 BD SYRINGE 5ML LS 24X1 DN EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLEARLY VISIBLE FOREIGN PARTICLES / STOPPER'S DRY ARTICLES INSIDE THE SEALED PACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD SYRINGE 5ML LS 24X1 DN EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLEARLY VISIBLE FOREIGN PARTICLES / STOPPER'S DRY ARTICLES INSIDE THE SEALED PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015803 BD SYRINGE 5ML LS 24X1 DN PISTON SYRINGE FMF BECTON DICKINSON 1030357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown