BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 16947028 · Received May 17, 2023

    Report

    Report Number
    8041187-2023-00217
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 19, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 17-MAY-2023. REVIEW OF THE DHR SHOWED THAT THE HOUSEKEEPING IS PERFORMED PER SHIFT PER 90005451 WITH NO ABNORMALITY OBSERVED. CURRENT CONTROL THERE IS A 3 HOURLY OUTGOING INSPECTION (SAMPLE SIZE: 800 PER DAY) AND 2 HOURLY IN-PROCESS INSPECTION (SAMPLE SIZE: 100 UNITS PER 2 HOURLY) IN PLACE TO CHECK FOR FOREIGN MATTER. THE BLACK DUST FOREIGN MATTER INSIDE THE PACKAGE AND SYRINGE COULD BE DUE TO PEST INFESTATION. THE FOREIGN MATTER COULD HAVE BEEN BROUGHT INTO 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 NONCONFORMANCE 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 NONCONFORMANCE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H3. 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 LUER-LOK SYRINGE EXPERIENCED DAMAGE PACKAGING WHERE STERILITY OF THE PRODUCT IS COMPROMISED AND FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOCTOR HAS COMPLAINT ABOUT DUST PARTICLES PRESENT IN 1ML SYRINGE. HE COMPLAINT VIA DSR OF VAR. PACKAGING IS NOT INTACT , SOME HOLES ARE VISIBLE IN PACKET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE EXPERIENCED DAMAGE PACKAGING WHERE STERILITY OF THE PRODUCT IS COMPROMISED AND FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOCTOR HAS COMPLAINT ABOUT DUST PARTICLES PRESENT IN 1ML SYRINGE. HE COMPLAINT VIA DSR OF VAR. PACKAGING IS NOT INTACT, SOME HOLES ARE VISIBLE IN PACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584647 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 1258698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown