BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 16261474 · Received January 28, 2023

    Report

    Report Number
    3003152976-2023-00009
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    December 14, 2022
    Report Date
    March 13, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION HAVE BEEN PROVIDED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111021, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 2111021 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO FOREIGN MATTER OR OTHER LIQUID WAS OBSERVED INSIDE ANY OF THE SYRINGES. IT IS POSSIBLE THE LIQUID THAT WAS DESCRIBED TO BE OBSERVED IN THE SYRINGE WAS SILICONE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOT 2111021 AND FOUND TO BE WITHIN SPECIFICATION. SILICONE CAN BE VISIBLE DUE TO ISSUES RELATED TO POOR DISTRIBUTION INSIDE THE BARREL. AS NO DEFECT WAS OBSERVED IN THE RETAINED SAMPLES AND DEVICE RECORDS DO NOT INDICATE ANY ISSUES OCCURRED DURING MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RELEASE OF SILICONE FROM THE PLUNGER OF THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RELEASE OF SILICONE FROM THE PLUNGER OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372109 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111021 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown