BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    MDR report key: 13337968 · Received January 24, 2022

    Report

    Report Number
    3003152976-2022-00018
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 5, 2022
    Report Date
    May 4, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SAMPLES FOR THIS COMPLAINT WERE SENT BY THE CUSTOMER; HOWEVER, WE ARE UNABLE TO LOCATE THEM AT THIS TIME. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110118, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED 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 AND VACUUM SYSTEM USED TO REMOVE ANY 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. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT AND REDUCE PARTICLES FROM GENERATING. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BETWEEN THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE BORE AND PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALSO, I HAVE ALSO BEEN SENT UP A BD 10ML SYRINGE WITH AN OBJECT INSIDE THE BORE, BETWEEN THE BORE AND PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BETWEEN THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE BORE AND PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ALSO, I HAVE ALSO BEEN SENT UP A BD 10ML SYRINGE WITH AN OBJECT INSIDE THE BORE, BETWEEN THE BORE AND PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614872 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110118

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown