BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN SYRINGE U40

    MDR report key: 7636552 · Received June 25, 2018

    Report

    Report Number
    1920898-2018-00430
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 4, 2018
    Report Date
    August 22, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1/2CC, 8MM, 30G U40 BD SYRINGE IN AN OPEN POLY BAG FROM LOT # 7142850. CUSTOMER STATES THAT THE BLACK STOPPER IS MISSING. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A MISSING STOPPER CAUSING THE PLUNGER TO BE LOOSE. NO DAMAGE TO THE PLUNGER ROD WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7142850. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (LOOSE PLUNGER AND MISSING STOPPER). INVESTIGATION CONCLUSION: PROBABLE ROOT CAUSE FOR MISSING STOPPER: AT THE STOPPER ASSEMBLY ON THE METRO MACHINE AS THE DIAL FOR THE PLUNGER COMES AROUND FOR THE MARRIAGE OF THE STOPPER TO PLUNGER, A PLUNGER COULD GET HUNG UP IN THE DIAL AND NOT ALLOW THE STOPPER TO ASSEMBLE TO THE PLUNGER.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ INSULIN SYRINGE U40 WAS FOUND WITH A LOOSE AND/OR MISSING STOPPER. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ INSULIN SYRINGE U40 WAS FOUND WITH A LOOSE AND/OR MISSING STOPPER. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD¿ INSULIN SYRINGE U40 WAS FOUND WITH A LOOSE AND/OR MISSING STOPPER. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475267 BD¿ INSULIN SYRINGE U40 INSULIN SYRINGE FMI BD MEDICAL - DIABETES CARE 7142850

    Patients

    Seq Age Sex Outcome Treatment
    1 Other