BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ DEMI INSULIN SYRINGE

    MDR report key: 14382979 · Received May 12, 2022

    Report

    Report Number
    1920898-2022-00331
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 8, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 17-MAY-2022. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (13) 0.3ML, 30 GAUGE, 8MM SYRINGES FROM LOT 0090628. NO ISSUES WITH THE GRADUATION MARKS COULD BE OBSERVED DURING VISUAL INSPECTION. EACH OF THE SYRINGES WERE OBSERVED UNDER A MICROSCOPE WITH A GAUGE TO ENSURE THAT THE GRADUATION MARKS WERE STRAIGHT AND EVEN. NONE OF THE SYRINGES WERE FOUND TO BE OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090628. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR SCRATCHED PRINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SCALE MARKINGS BEING MISALIGNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MICRO-FINE¿+ DEMI INSULIN SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT COMPLAINED ABOUT THE INSULIN SYRINGES BECAUSE THE SCALE WAS PRINTED AT AN ANGLE. THE PHARMACIST THEN DETERMINED THAT THIS PROBLEM WAS THE CASE WITH ALMOST ALL 100 PACKAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD MICRO-FINE¿+ DEMI INSULIN SYRINGES EXPERIENCED SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT COMPLAINED ABOUT THE INSULIN SYRINGES BECAUSE THE SCALE WAS PRINTED AT AN ANGLE. THE PHARMACIST THEN DETERMINED THAT THIS PROBLEM WAS THE CASE WITH ALMOST ALL 100 PACKAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415732 BD MICRO-FINE¿+ DEMI INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0090628

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown