BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14414717 · Received May 17, 2022

    Report

    Report Number
    3003152976-2022-00217
    Event Type
    Malfunction
    Date Received
    May 17, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 24, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE TIP IS OBSERVED TO BE DEFORMED, NO DEFECT WAS NOTED WITHIN THE SYRINGE LUER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2202079 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. MOLDING PARAMETERS WERE REVIEWED FOR LOT 2202079 AND MACHINES WERE VERIFIED TO BE OPERATING WITHIN REQUIRED LIMITS. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE DAMAGED OBSERVED LIKELY OCCURRED DURING THE MOLDING PROCESS WHEN THE PIECE WAS EJECTED FROM THE MOLD, CAUSING THE TIP TO BECOME DEFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LUER TIP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I¿M WRITING TO REPORT A FAULTY 50ML SYRINGE WHICH LOOKS AS THOUGH THERE HAS BEEN A MANUFACTURING ERROR. THE CENTRAL LUMEN OF THE LUER LOCK PORTION LOOKS TO HAVE NOT BEEN FORMED PROPERLY OR HAS POSSIBLY MELTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LUER TIP WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I¿M WRITING TO REPORT A FAULTY 50ML SYRINGE WHICH LOOKS AS THOUGH THERE HAS BEEN A MANUFACTURING ERROR. THE CENTRAL LUMEN OF THE LUER LOCK PORTION LOOKS TO HAVE NOT BEEN FORMED PROPERLY OR HAS POSSIBLY MELTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691589 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown