BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 12364986 · Received August 25, 2021

    Report

    Report Number
    3002682307-2021-00431
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 27, 2021
    Report Date
    November 16, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2003221. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, A RED PARTICLE INSIDE OF THE SYRINGE WAS OBSERVED. THE RED PARTICLE WAS IDENTIFIED AS PLASTIC FROM ONE OF THE PLASTIC PIECES INSTALLED IN THE AIR CONVEYOR SYSTEM WHICH RECEIVES THE BARRELS BEFORE THEIR ENTRANCE TO THE ASSEMBLY MACHINE. THE PRESENCE OF THIS PARTICLE IN THE SYRINGE IS DUE TO A TEAR IN THE PLASTIC CONVEYOR PIECE CAUSED BY CONTINUOUS IMPACT. THIS TYPE OF SITUATION SHOULD NOT OCCUR IF THE CONDITIONS ARE OPTIMUM AND THEREFORE, WAS A CONSEQUENCE OF POOR CONDITIONS OF THIS COMPONENT OF THE CONVEYOR SYSTEM. THIS COMPONENT SHOULD HAVE BEEN REPLACED PRIOR TO THIS ISSUE OCCURRING. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD DISCARDIT¿ II SYRINGE EACH FROM LOTS 2011205 AND 2003221 HAD FOREIGN MATTER IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A COUPLE OF COMPLAINTS FROM ONE CUSTOMER ABOUT A RED PARTICLE IN A SYRINGE. THE FIRST TIME A SAMPLE WAS PROVIDED, AND I DID A MICROSCOPIC IMAGE OF IT, TO SEE IF I COULD WORK OUT THE TYPE OF MATERIAL ¿ WE COULD NOT DETERMINE A ROOT CAUSE AND NOTHING ELSE IN THE PROCEDURE PACK MATCHED. NOW THE SAME CUSTOMER SAYS THEY FOUND ANOTHER PARTICLE; IT¿S A DIFFERENT BATCH OF SYRINGES AND NO SAMPLE THIS TIME."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2011205, MEDICAL DEVICE EXPIRATION DATE: 2025-10-31, DEVICE MANUFACTURE DATE: 2020-11-05. MEDICAL DEVICE LOT #: 2003221, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: 2020-03-09. 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 · 1

    IT WAS REPORTED THAT 1 BD DISCARDIT¿ II SYRINGE EACH FROM LOTS 2011205 AND 2003221 HAD FOREIGN MATTER IN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A COUPLE OF COMPLAINTS FROM ONE CUSTOMER ABOUT A RED PARTICLE IN A SYRINGE. THE FIRST TIME A SAMPLE WAS PROVIDED, AND I DID A MICROSCOPIC IMAGE OF IT, TO SEE IF I COULD WORK OUT THE TYPE OF MATERIAL ¿ WE COULD NOT DETERMINE A ROOT CAUSE AND NOTHING ELSE IN THE PROCEDURE PACK MATCHED. NOW THE SAME CUSTOMER SAYS THEY FOUND ANOTHER PARTICLE; IT¿S A DIFFERENT BATCH OF SYRINGES AND NO SAMPLE THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261366 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown