BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 11646140 · Received April 9, 2021

    Report

    Report Number
    3003152976-2021-00191
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    October 9, 2020
    Report Date
    May 13, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO AND ONE PHYSICAL SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTING THE PRODUCT, THE LIQUID INSIDE THE SYRINGE IS OBSERVED TO HAVE A PINK DISCOLORATION, IT IS NOT COMPLETELY TRANSPARENT, INDICATING OXIDATION MAY HAVE OCCURRED. THERE ARE NO DEFECTS IDENTIFIED WITHIN THE SYRINGE THAT COULD HAVE CONTRIBUTED TO ANY DISCOLORATION OR OXIDATION OF THE LIQUID. 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. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1910304, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. STERILIZATION RECORDS VERIFIED THE PRODUCT WAS PROPERLY STERILIZED ACCORDING TO PROCEDURE, NO ISSUES OR DEVIATIONS OCCURRED DURING THIS PROCESS. EVALUATIONS ARE PERFORMED TO EVALUATE REMAINING ETHYLENE OXIDE RESIDUES AFTER STERILIZATION. ALL RECORDS FOR LOT 1910304 WERE FOUND TO BE WITHIN THE REQUIRED LIMITS. THERE HAVE BEEN NO CHANGES IN THE MANUFACTURING PROCESS OR MATERIALS USED TO MANUFACTURE THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. BASED UPON THE AVAILABLE INFORMATION, WE WERE UNABLE TO DETERMINE A ROOT CAUSE RELATED TO THE SYRINGE OR OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL INFORMATION: WE HAVE RECENTLY ((B)(6) 2020 & (B)(6) 2021) RECEIVED 2 COMPLAINTS WHERE A PREPARATION OF OURS (PRODUCED IN THE BD SYRINGE 300865) SHOWED A PINK DISCOLORATION AFTER STORAGE. HOWEVER, IN BOTH CASES THIS WAS LIMITED TO ONE SYRINGE (DESPITE THE FACT THAT THE SYRINGES WERE PACKAGED IN PAIRS AND THUS UNDERWENT THE SAME STORAGE CONDITIONS AS THEIR NON-DISCOLORED COUNTERPART). THE PINK DISCOLORATION IN THIS CASE INDICATES AN OXIDATION OF ADRENALINE, ONE OF THE COMPONENTS. GIVEN THAT BOTH COMPLAINTS ARE LIMITED TO ONE SYRINGE, WE CONCLUDE THAT THE OXIDATION REACTION IS CAUSED BY THE SYRINGE, BUT THAT IT IS NOT CONSISTENTLY PRESENT IN ALL SYRINGES. IN THIS REGARD, WE ARE THINKING POSSIBLY OF A RESIDUAL ETHYLENE OXIDE (GIVEN THE STERILIZATION METHOD) OR AN OXIDATIVE PARTICLE (ALTHOUGH AFTER VISUAL INSPECTION NO PARTICLE COULD BE DETECTED).

    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 50ML LL WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ADDITIONAL INFORMATION: WE HAVE RECENTLY ((B)(6) 2020 & (B)(6) 2021) RECEIVED 2 COMPLAINTS WHERE A PREPARATION OF OURS (PRODUCED IN THE BD SYRINGE 300865) SHOWED A PINK DISCOLORATION AFTER STORAGE. HOWEVER, IN BOTH CASES THIS WAS LIMITED TO ONE SYRINGE (DESPITE THE FACT THAT THE SYRINGES WERE PACKAGED IN PAIRS AND THUS UNDERWENT THE SAME STORAGE CONDITIONS AS THEIR NON-DISCOLORED COUNTERPART). THE PINK DISCOLORATION IN THIS CASE INDICATES AN OXIDATION OF ADRENALINE, ONE OF THE COMPONENTS. GIVEN THAT BOTH COMPLAINTS ARE LIMITED TO ONE SYRINGE, WE CONCLUDE THAT THE OXIDATION REACTION IS CAUSED BY THE SYRINGE, BUT THAT IT IS NOT CONSISTENTLY PRESENT IN ALL SYRINGES. IN THIS REGARD, WE ARE THINKING POSSIBLY OF A RESIDUAL ETHYLENE OXIDE (GIVEN THE STERILIZATION METHOD) OR AN OXIDATIVE PARTICLE (ALTHOUGH AFTER VISUAL INSPECTION NO PARTICLE COULD BE DETECTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542363 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1910304

    Patients

    Seq Age Sex Outcome Treatment
    1