BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 10ML SYRINGE

    MDR report key: 6871171 · Received September 15, 2017

    Report

    Report Number
    3002682307-2017-00059
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 14, 2017
    Report Date
    October 30, 2017
    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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE PROVIDED PICTURE, SAMPLE SHOWED A BIG AMOUNT OF SILICONE STICKED AT THE STOPPER OF THE SYRINGE, WE COULD CONFIRM THE REPORTED ISSUE. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7132436, AND #7128260 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. THE ORIGIN OF THE REPORTED NONCONFORMANCE CONSISTED OF SILICONE OIL. THIS SILICONE OIL IS USED TO LUBRICATE THE INNER PART OF THE BARREL AND FACILITATE THE MOVEMENT OF THE PLUNGER ROD. CORRECT PRESENCE AND QUANTITY OF SILICONE IN THE SYRINGE IS EVALUATED IN OUR ROUTINE MANUFACTURING CONTROLS. IN THAT CASE, WE CONSIDER THAT BECAUSE OF SOME TEMPORARY ISSUE IN THE SILICONIZATION PROCESS, THERE WAS AN EXCESS OF SILICONE CAUSING THE REPORTED NON CONFORMANCE. ON THE OTHER HAND, BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CONFIDENT THAT THIS HAS BEEN AN ISOLATED CASE AND ANY PROBABILITY OF OCCURRENCE SHOULD BE VERY EXCEPTIONAL. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GREASY RESIDUE WAS FOUND IN A BD EMERALD¿ 10ML SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648046 BD EMERALD¿ 10ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1705377

    Patients

    Seq Age Sex Outcome Treatment
    1 Other