BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK 30 ML SYRINGE

    MDR report key: 9069746 · Received September 16, 2019

    Report

    Report Number
    3003152976-2019-00624
    Event Type
    Malfunction
    Date Received
    September 16, 2019
    Date of Event
    August 29, 2019
    Report Date
    October 15, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE AND ONE PHOTO WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THE SAMPLE WAS VISUALLY INSPECTED, NO DEFECT WAS OBSERVED ON THE PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOTS 1811217 AND 1903204 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THE RIDGES ON THE PACKAGING REPORTED BY THE CUSTOMER ARE FORMED DURING THE PACKAGING PROCESS. THE FORMING DYE HAS HOLES WHICH ARE REQUIRED TO APPLY VACUUM DURING THE FILM FORMING PROCESS. THESE RIDGES FORM AS A RESULT OF THIS DESIGN AND DO NOT AFFECT THE FUNCTIONALITY OR STERILITY OF THE SYRINGE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. ALLEGED DEFECT IS AN AESTHETIC APPEARANCE RESULT OF SEALING DIE DESIGN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE HAD STERILITY ISSUES. THIS OCCURRED ON 60 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF REPORTED RUNNING THEIR FINGERS ALONG THE PACKAGING OF THE SYRINGES AND FEELING RIDGES ON THEM WHICH FEELS UNUSUAL AND STAFF ARE CONCERNED THE SYRINGES ARE NO LONGER STERILE. THEY CANNOT TELL IF THE BUMPS AND RIDGES HAVE BROKEN THROUGH THE WRAPPING.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1811217, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2018-11-07. MEDICAL DEVICE LOT #: 1903204, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-04. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE HAD STERILITY ISSUES. THIS OCCURRED ON 60 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF REPORTED RUNNING THEIR FINGERS ALONG THE PACKAGING OF THE SYRINGES AND FEELING RIDGES ON THEM WHICH FEELS UNUSUAL AND STAFF ARE CONCERNED THE SYRINGES ARE NO LONGER STERILE. THEY CANNOT TELL IF THE BUMPS AND RIDGES HAVE BROKEN THROUGH THE WRAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868052 BD PLASTIPAK LUER-LOK 30 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other