BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR

    MDR report key: 11767917 · Received May 4, 2021

    Report

    Report Number
    1920898-2021-00516
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A SINGLE IMAGE OF A 0.3ML SYRINGE WITH NO OTHER IDENTIFICATION PROVIDED. THE IMAGE SHOWS THAT THE PLUNGER ROD HAS FRACTURED APPROXIMATELY 2CM FROM ITS BASE. WHILE THE PARTS ARE STILL CONNECTED, THE PLUNGER¿S BASE IS SKEWED SIGNIFICANTLY TO ONE SIDE AND ANY USAGE MAY SIMPLY EXACERBATE THE DAMAGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 9042904 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE IMAGE PROVIDED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF A BROKEN PLUNGER ROD. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR PLUNGER ROD WAS BROKEN. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USES THE SYRINGES TO APPLY BOTULINIC TOXIN IN HER CLINIC, AND IN THE BATCH REPORTED, TWO SYRINGES WERE WITH THE PLUNGER ROD BROKEN. SHE NOTICED THE ISSUE AS SOON AS SHE REMOVED THE SAFETY SHIELD FROM THE PLUNGER.

    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 0.3ML 30GA 8MM 10BAG 500 L AMR PLUNGER ROD WAS BROKEN. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USES THE SYRINGES TO APPLY BOTULINIC TOXIN IN HER CLINIC, AND IN THE BATCH REPORTED, TWO SYRINGES WERE WITH THE PLUNGER ROD BROKEN. SHE NOTICED THE ISSUE AS SOON AS SHE REMOVED THE SAFETY SHIELD FROM THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664299 SYRINGE 0.3ML 30GA 8MM 10BAG 500 L AMR SYRINGE FMF BD MEDICAL - DIABETES CARE 9042904

    Patients

    Seq Age Sex Outcome Treatment
    1