BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14738769 · Received June 17, 2022

    Report

    Report Number
    3003152976-2022-00276
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    May 18, 2022
    Report Date
    July 26, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 15-JUN-2022. H6: INVESTIGATION SUMMARY ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, FOREIGN MATTER WAS OBSERVED WITHIN THE SYRINGE. FURTHER EVALUATION IDENTIFIED THE MATTER TO BE GREASE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR POTENTIAL LOT 2203079, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING EQUIPMENT AND MACHINES UNDERGOES CLEARLY DEFINED CLEANING. 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, NO ISSUES RELATED TO THIS INCIDENT WERE FOUND DURING MANUFACTURING. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE GREASE LIKELY ACCUMULATED IN THE MOLD DURING THE MOLDING PROCESS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE APPEARS TO BE A DEPOSIT ON EITHER THE PLUNGER OR THE ML MARKINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE APPEARS TO BE A DEPOSIT ON EITHER THE PLUNGER OR THE ML MARKINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737410 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown