BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE

    MDR report key: 16950107 · Received May 17, 2023

    Report

    Report Number
    1920898-2023-00301
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 24, 2023
    Report Date
    August 3, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 19MAY2023. H6: INVESTIGATION SUMMARY. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 2122408 FOR FOREIGN MATTER IN SYRINGE. THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER IN SYRINGE ON LOT # 2122408. INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE 0.5ML 30GA 8MM SYRINGE IN AN OPEN POLYBAG FROM LOT# 2122408. REPORTING THAT THERE IS SOMETHING INSIDE THE INSULIN SYRINGE. THE SYRINGE WAS VISUALLY INSPECTED AND OBSERVED TWO SMALL WHITE MATERIALS INSIDE THE BARREL. THESE TWO WHITE MATERIALS WERE REMOVED OUT OF THE BARREL, THE LENGTHS OF EACH MATERIAL WERE 0.097 INCHES, 0.091 INCHES APPROXIMATELY AND BOTH MATERIALS WERE PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY ASTRAZENECA COVID VACCINE VIAL SEPTUM. SEE ATTACHED FTIR SPECTRA. FUNCTIONALITY TEST WAS PERFORMED ON THE SYRINGE AND OBSERVED PROPER FLOW THROUGH THE CANNULA. MANUFACTURING HOLDREGE WILL BE NOTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2122408. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CONFIRMED: EMBECTA WAS ABLE TO CONFIRM THE FOREIGN MATERIAL AS ASTRAZENECA COVID VACCINE VIAL SEPTUM. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH THERE IS SOMETHING INSIDE THE INSULIN SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM KOREAN TO ENGLISH THERE IS SOMETHING INSIDE THE INSULIN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380682 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2122408

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown