BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10209505 · Received June 29, 2020

    Report

    Report Number
    3003152976-2020-00273
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 8, 2020
    Report Date
    July 17, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, MATERIAL WAS OBSERVED INSIDE THE SYRINGE WHICH IS BELIEVED TO BE EXCESS SILICONE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1910212, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER, RESULTS WERE REVIEWED FOR LOT 1910212 AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 11 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES WERE FOUND WITH DIRTY TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "DIRTY AT THE SYRINGE TIP".

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 11 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES WERE FOUND WITH DIRTY TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DIRTY AT THE SYRINGE TIP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674220 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1910212

    Patients

    Seq Age Sex Outcome Treatment
    1 Other