BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL

    MDR report key: 10312352 · Received July 23, 2020

    Report

    Report Number
    3003152976-2020-00316
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 2, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON:(B)(6)2020. H.6. INVESTIGATION: ONE SAMPLE OF LOT 2001295 ALONG WITH THE SAMPLE CONNECTOR USED WITH SYRINGE, WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLES WERE VISUALLY INSPECTED, THERE WAS NO DAMAGE TO THE CONNECTION THREAD OF THE PRODUCT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2001295 AND 2001294, 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, INCLUDING TIP AND THREAD VERIFICATIONS. TESTING WAS PERFORMED ON THE PRODUCT RETURNED AND FOUND THE LUER DID COMPLY WITH ISO STANDARDS. FUNCTIONAL TESTING WAS COMPLETED, FILLING THE SYRINGE WITH WATER AND CONNECTING TO THE CONNECTION DEVICE THAT WAS USED. WATER PASSED THROUGH DEVICE AND NO LEAK WAS OBSERVED. IT WAS NOTED ONE OF THE CONNECTION DEVICES, WHICH IS NOT MANUFACTURED BY BD, APPEARED TO HAVE BEEN OVER SCREWED AND THE CONNECTION STICK WAS MOVING, WHICH MAY HAVE CONTRIBUTED TO THE LEAK REPORTED. BASED ON OUR INVESTIGATION, NO DEFECT WAS OBSERVED ON OUR SYRINGE, AND DEVICE RECORDS PROVIDED NO INCIDENTS RELATED TO THE REPORTED FAILURE, THEREFORE A ROOT CAUSE RELATED TO OUR PRODUCT AND MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 30ML LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER HAS EXPLAINED THAT FOR THE LAST SIX WEEKS THAT WHILE PREPARING CHEMOTHERAPY IN THE ASEPTIC UNIT THAT CHEMO HAS LEAKED BETWEEN BD SYRINGES AND THE CLOSED SYSTEM TRANSFER DEVICE USED BELOW. THEY WERE WONDERING WHETHER THERE HAVE BEEN ANY MANUFACTURING OR ANY CHANGES MADE TO THE BD SYRINGES IN THE LAST WHILE. THIS HAS BEEN AN ONGOING ISSUE FOR THE LAST 6 WEEKS. THEY BELIEVE THE ISSUE RELATES TO THE CLOSED CHEMO DEVICE BUT AS THIS IS SUCH A SAFETY ISSUE WOULD LIKE TO INVESTIGATE EVERY ASPECT OF THE DRAWING UP PROCESS (INCLUDING OUR SYRINGES) THE CUSTOMER CAN MAKE AVAILABLE ANY SAMPLES WE WANT. CAN THE INVESTIGATING TEAM ADVICE WHAT THEY WOULD LIKE.".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 30 ML LL LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER HAS EXPLAINED THAT FOR THE LAST SIX WEEKS THAT WHILE PREPARING CHEMOTHERAPY IN THE ASEPTIC UNIT THAT CHEMO HAS LEAKED BETWEEN BD SYRINGES AND THE CLOSED SYSTEM TRANSFER DEVICE USED BELOW. THEY WERE WONDERING WHETHER THERE HAVE BEEN ANY MANUFACTURING OR ANY CHANGES MADE TO THE BD SYRINGES IN THE LAST WHILE. THIS HAS BEEN AN ONGOING ISSUE FOR THE LAST 6 WEEKS. THEY BELIEVE THE ISSUE RELATES TO THE CLOSED CHEMO DEVICE BUT AS THIS IS SUCH A SAFETY ISSUE WOULD LIKE TO INVESTIGATE EVERY ASPECT OF THE DRAWING UP PROCESS (INCLUDING OUR SYRINGES) THE CUSTOMER CAN MAKE AVAILABLE ANY SAMPLES WE WANT. CAN THE INVESTIGATING TEAM ADVICE WHAT THEY WOULD LIKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782407 SYRINGE 30ML LL SYRINGE FMF BECTON DICKINSON, S.A. 2001294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other