BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    MDR report key: 15997167 · Received December 16, 2022

    Report

    Report Number
    3003152976-2022-00568
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 25, 2022
    Report Date
    January 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 02-JAN-2023. H6: INVESTIGATION SUMMARY: MULTIPLE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SEALING CORD IS OBSERVED TO BE PROPERLY FORMED. TWO UNIT PACKAGES SHOW DAMAGE FROM ATTEMPTING TO SEPARATE. WHEN PERFORMING SEPARATION, IT WAS NOTED TO BE DIFFICULT. IT WAS IDENTIFIED THAT THE PRE-CUTTING OF THE BLISTERS WAS NOT COMPLETE, MAKING IS DIFFICULT TO SEPARATE THE PACKAGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2210024, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. DURING PACKAGING, AFTER THE BLISTERS ARE SEALED, CUTTERS CUT THE PACKAGING, CREATING THE DOTTED LINE TO ALLOW FOR SMOOTH SEPARATION. 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. WHILE OUR DEVICE RECORDS ESTABLISHED ALL QUALITY PROCEDURES WERE CARRIED OUT WITHOUT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE TO THE INCORRECT CUTTING DURING THE PACKAGING PROCESS.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PERFORATION ON THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PACKAGING UNITS WAS POOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR COMPLAINT IS ABOUT THE PACKAGING. THE PERFORATION BETWEEN THE SYRINGES IS NOT GOOD AND THIS MEANS THAT THE SYRINGES ARE "DIFFICULT" TO TEAR APART AND IT HAPPENS THAT I TEAR HOLES IN THE PACKAGING OF INDIVIDUAL SYRINGES WHEN I WANT TO SPLIT THEM APART."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PERFORATION ON THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PACKAGING UNITS WAS POOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OUR COMPLAINT IS ABOUT THE PACKAGING. THE PERFORATION BETWEEN THE SYRINGES IS NOT GOOD AND THIS MEANS THAT THE SYRINGES ARE "DIFFICULT" TO TEAR APART AND IT HAPPENS THAT I TEAR HOLES IN THE PACKAGING OF INDIVIDUAL SYRINGES WHEN I WANT TO SPLIT THEM APART."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084951 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2210024

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown