BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 8613527 · Received May 15, 2019

    Report

    Report Number
    1920898-2019-00453
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 29, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (5) 1CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 6221541. CUSTOMER STATES THAT WHEN SHE REMOVED THE ORANGE PROTECTIVE CAP SHE IDENTIFIED A FOREIGN OBJECT IN THE NEEDLE. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SYRINGE EXHIBITED AN ORANGE PIECE OF MATERIAL ON THE SURFACE OF THE CANNULA SHAFT. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYETHYLENE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 6221541. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. PROBABLE ROOT CAUSE OF THE OF THE PLASTIC ON THE CANNULA IS FROM REGRIND PARTICLES THAT WERE NOT SEPARATED PROPERLY FROM THE SHIELD COMPONENTS IN THE MOLDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE WHEN THE CONSUMER REMOVED THE PROTECTIVE CAP SHE IDENTIFIED A FOREIGN OBJECT IN THE NEEDLE (LINT). FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN SHE REMOVED THE ORANGE PROTECTIVE CAP SHE IDENTIFIED A FOREIGN OBJECT IN THE NEEDLE (LINT).

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE WHEN THE CONSUMER REMOVED THE PROTECTIVE CAP SHE IDENTIFIED A FOREIGN OBJECT IN THE NEEDLE (LINT). FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN SHE REMOVED THE ORANGE PROTECTIVE CAP SHE IDENTIFIED A FOREIGN OBJECT IN THE NEEDLE (LINT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404164 BD ULTRA-FINE INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 6221541

    Patients

    Seq Age Sex Outcome Treatment
    1 Other