BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7776629 · Received August 13, 2018

    Report

    Report Number
    3002682307-2018-00202
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 26, 2018
    Report Date
    September 13, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: NO. INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, WE CONFIRMED THE REPORTED ISSUE, AND IDENTIFIED THE FOREIGN MATTER AS POLISHING PASTE COMING FROM THE MOLD OF THE INJECTION AREA. DHR REVIEW FOR LOT # 1805179: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2017 (MAY 25TH ¿ 26TH, 2018). NEEDLES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4235, Nº4213, Nº4212, Nº4203, IN LOT #8110871 (APRIL 23RD ¿ 30TH, 2018), IN LOT #8127718 (MAY 7TH ¿ 14TH, 2018), IN LOT #8134776 (MAY 14TH ¿ 21ST, 2018), AND IN LOT #8141660 (MAY 21ST ¿ 28TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8114940, #8107652, #8099993, #8142762, #8135532, #8128590, #8119952, #8103507, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. AFTER ANALYZING THE AFFECTED SAMPLE PROVIDED TO THE MANUFACTURING SITE FOR EVALUATION, WE COULD SEE THE REPORTED FOREIGN MATTER AND CONFIRM THE REPORTED ISSUE. ONE OF THE MAINTENANCE ACTIVITIES PERFORMED ON AN INJECTION MOLD, IS POLISH THE MALES OF THIS MOLD WHEN NEEDED. FOR THIS TASKS, THE OPERATORS USE A POLISHING PASTE, AND AFTER PERFORMING THE TASK THEY HAVE TO REMOVE THE EXCESS OF THIS PASTE FROM THE MOLD. IN THIS CASE, DUE TO A PUNCTUAL FAILURE IN THIS MANUFACTURING PROCEDURE, THIS PASTE WAS NOT REMOVED FROM THE MOLD AND FINALLY A SMALL QUANTITY OF IT REMAIN INSIDE THE TIP OF ONE BARREL. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS LOW AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD DISCARDIT¿ II SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD DISCARDIT¿ II SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620355 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1805179

    Patients

    Seq Age Sex Outcome Treatment
    1 Other