BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE

    MDR report key: 7646643 · Received June 28, 2018

    Report

    Report Number
    3003152976-2018-00258
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 7, 2018
    Report Date
    August 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE ACTUAL SAMPLE WAS RETURNED FOR EVALUATION. INVESTIGATION SUMMARY: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE SAMPLE, EXCESS SILICONE WAS OBSERVED WITHIN THE SYRINGE. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DEVIATIONS OR NON-CONFORMANCES DURING THE PRODUCTION OF LOT NUMBER 1803254 THAT COULD HAVE CONTRIBUTED TO THE OBSERVED DEFECT. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. MEDICAL GRADE SILICONE IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS AS A LUBRICANT WITHIN THE SILICONE STATION. A FAILURE WITHIN THE SILICONE SPRAYER ASSEMBLY STATION RESULTED IN THE EXCESS SILICONE OBSERVED ON THE RETURNED SAMPLE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE. ALTHOUGH NO ISSUES WERE IDENTIFIED AND MANUFACTURING RECORD STABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY, WE CAN CONFIRM THAT THE ROOT CAUSE OF THE NON-CONFORMANCE IS RELATED WITH A FAILURE OF SILICONE SPRAYER IN ASSEMBLY STATION. IN ACCORDANCE, WE CONCLUDE THAT THE ROOT CAUSE OF THE PROBLEM WAS RELATED WITH A MECHANICAL FAILURE. BASED ON OCCURRENCE IT WAS DETERMINED NO FORMAL CAPA IS REQUIRED AT THIS TIME.

    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 FIELD: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGES CONTAINED FOREIGN MATTER. IT WAS STATED, "THE SYRINGE SEEMS TO CONTAIN AN OILY LIQUID." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGES CONTAINED FOREIGN MATTER. IT WAS STATED, "THE SYRINGE SEEMS TO CONTAIN AN OILY LIQUID." NO REPORT OF SERIOUS INJURY OR 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 THAT BD PLASTIPAK¿ SYRINGES CONTAINED FOREIGN MATTER. IT WAS STATED, "THE SYRINGE SEEMS TO CONTAIN AN OILY LIQUID." NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488599 BD PLASTIPAK¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1803254

    Patients

    Seq Age Sex Outcome Treatment
    1 Other