BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE

    MDR report key: 14777710 · Received June 22, 2022

    Report

    Report Number
    3003152976-2022-00287
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 27, 2022
    Report Date
    July 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 15-JUN-2022. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE SEALING CORD IS OBSERVED TO BE OPENED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201007, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED 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. RESULTS WERE REVIEWED AND VERIFIED THE PACKAGING MET REQUIRED SPECIFICATION. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THIS ISSUE WAS LIKELY A RESULT OF A FAILURE IN THE PACKAGING PROCESS, ALTHOUGH THE DEVICE RECORDS DO NOT INDICATE ANY ISSUES OR A DEFINITIVE CAUSE RELATED TO THIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING A BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE, THE STERILITY OF THE UNIT PACKAGE WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE NOTICED THAT SEVERAL SYRINGES ARE BADLY PACKED; NOT SEALED; NOT STERILE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING A BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE, THE STERILITY OF THE UNIT PACKAGE WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE NOTICED THAT SEVERAL SYRINGES ARE BADLY PACKED -> NOT SEALED -> NOT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332169 BD PLASTIPAK¿ PLASTIC CONCENTRIC LUER-LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201007

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown