BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL

    MDR report key: 12193977 · Received July 19, 2021

    Report

    Report Number
    3003152976-2021-00402
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 17, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SMALL DOTS CAN BE OBSERVED ON THE BOTTOM BLISTER. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES OR NON-CONFORMANCES DURING THE PRODUCTION OF LOT NUMBER 2010002 THAT COULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. DURING THE PACKAGING PROCESS, THE FILM ON THE BOTTOM WEB OF THE PACKAGE IS FORMED USING HEAT PRESSURE AND VACUUM IN ORDER TO GIVE IT SHAPE TO LOCATE THE SYRINGE. THE DOTS OBSERVED ON THE PACKAGE ARE CREATED BY THE PACKAGING MACHINE WHEN THE VACUUM IS PRODUCED. THIS PROCESS HAS VALIDATED PARAMETERS TO ENSURE THE STERILITY OF THE PRODUCT. ALL RESULTS WERE REVIEWED AND VERIFIED TO BE WITHIN THE REQUIRED SPECIFICATIONS. THE AIR THAT WAS DESCRIBED TO BE OBSERVED BY THE CUSTOMER MAY BE RELATED TO THE PAPER PORTION OF THE PACKAGING. ADDITIONALLY, THE PAPER USED FOR THE BLISTER PACKAGING HAS SET REQUIREMENTS TO ENSURE PROPER PRODUCT STERILITY. RESULTS WERE REVIEWED AND CONFIRMED THE PAPER PROPERTIES MEETS REQUIRED ISO STANDARDS. 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. BASED ON OUR QUALITY TEAM'S INVESTIGATION AND GIVEN NO ISSUES WERE IDENTIFIED WITHIN OUR DEVICE RECORDS, A ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 30ML LL PACKAGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANAESTHETIST HAS QUESTIONED THE STERILITY OF THE BD SYRINGES WE STOCK ¿ IT DOES STATE STERILE /EO, BUT HAS VERY SMALL HOLES IN THE CLEAR SIDE OF THE PACKAGING. HE STATES THAT HE CAN SQUEEZE AIR OUT AND IT THEN ¿REFILLS¿.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 30ML LL PACKAGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANAESTHETIST HAS QUESTIONED THE STERILITY OF THE BD SYRINGES WE STOCK ¿ IT DOES STATE STERILE /EO, BUT HAS VERY SMALL HOLES IN THE CLEAR SIDE OF THE PACKAGING. HE STATES THAT HE CAN SQUEEZE AIR OUT AND IT THEN ¿REFILLS¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086757 SYRINGE 30ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2010002

    Patients

    Seq Age Sex Outcome Treatment
    1