BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 11152825 · Received January 11, 2021

    Report

    Report Number
    1920898-2021-00022
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 14, 2020
    Report Date
    April 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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 EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/18/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (6) LOOSE 3/10CC SYRINGES. CUSTOMER STATES THAT THERE WAS A SUBSTANCE ON THE PLUNGER ROD. ALL RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON THE PLUNGER RODS OR ANYWHERE ELSE ON THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0203534 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 HAD FOREIGN MATTER ON THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438 BATCH NO. 0203534. IT WAS REPORTED THAT THERE WAS A SUBSTANCE ON THE PLUNGER ROD. VERBATIM: PHARMACIST REPORTED COMPLAINT ON BEHALF OF CONSUMER. STATED THE 8MM SYRINGES HAVE SOME SORT OF OIL OR SUBSTANCE ON THE PLUNGER INSIDE OF THE BARREL. STATED THE CONSUMER NOTICED THIS WHEN DRAWING BACK THE PLUNGER AND RETURNED THE BOXES TO THE STORE. PHARMACIST PROVIDED REPLACEMENT. REPORTED SAME ISSUE WITH 6MM SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 0.3ML 31G 8MM WHOLE UNIT 10BG 500 HAD FOREIGN MATTER ON THE PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328438, BATCH NO. 0203534. IT WAS REPORTED THAT THERE WAS A SUBSTANCE ON THE PLUNGER ROD. VERBATIM: PHARMACIST REPORTED COMPLAINT ON BEHALF OF CONSUMER. STATED THE 8MM SYRINGES HAVE SOME SORT OF OIL OR SUBSTANCE ON THE PLUNGER INSIDE OF THE BARREL. STATED THE CONSUMER NOTICED THIS WHEN DRAWING BACK THE PLUNGER AND RETURNED THE BOXES TO THE STORE. PHARMACIST PROVIDED REPLACEMENT. REPORTED SAME ISSUE WITH 6MM SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42398 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 0203534 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1