BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE

    MDR report key: 11023871 · Received December 16, 2020

    Report

    Report Number
    3003152976-2020-00571
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 19, 2020
    Report Date
    February 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2020-11-27 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, FOREIGN MATTER WAS OBSERVED INSIDE THE SYRINGE, THERE WAS NO PARTICLES OR OTHER MATTER ON THE OUTSIDE OF THE SYRINGE. USING MAGNIFICATION THE MATTER WAS DETERMINED TO BE A POLYPROPYLENE PARTICLE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2004005, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER USED TO REMOVE ANY POLYPROPYLENE PARTICLES INSIDE THE BARREL. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE PARTICLES LIKELY GENERATED DURING THE MOVEMENT OF THE PRODUCT WITHIN THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGES HAD FOREIGN MATTER IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING FURTHER ISSUES WITH YOUR 10ML SYRINGES, WE HAVE BEEN MANUFACTURING IN THE ISOLATOR AND HAVE NOTICED AFTER UNPACKING YOUR SYRINGES THAT THEY HAVE BEEN DIRTY, SOME ON THE INSIDE AND SOME ON THE OUTSIDE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGES HAD FOREIGN MATTER IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE HAVING FURTHER ISSUES WITH YOUR 10ML SYRINGES, WE HAVE BEEN MANUFACTURING IN THE ISOLATOR AND HAVE NOTICED AFTER UNPACKING YOUR SYRINGES THAT THEY HAVE BEEN DIRTY, SOME ON THE INSIDE AND SOME ON THE OUTSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486464 BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2004005

    Patients

    Seq Age Sex Outcome Treatment
    1