BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 10841115 · Received November 14, 2020

    Report

    Report Number
    1920898-2020-01570
    Event Type
    Malfunction
    Date Received
    November 14, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 17, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 11/18/2020. H.6. INVESTIGATION: CUSTOMER RETURNED ONE (1) LOOSE 0.3ML BD INSULIN SYRINGE. CONSUMER REPORTED WHEN REMOVING THE ORANGE NEEDLE CAPS, THE WHOLE NEEDLE CAME OFF WITH THE CAP. THE RETURNED SAMPLE WAS EXAMINED, AND IT WAS OBSERVED THAT A NEEDLE HUB / SHIELD ASSEMBLY WAS SEPARATED; NO DAMAGE TO THE BARREL TIP WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200829078, 200828969] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA#: 1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 SYRINGE 0.3ML 31G 8MM WHOLE UNIT 10BG 500 SEPARATED FROM HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN REMOVING THE ORANGE NEEDLE CAPS, THE WHOLE NEEDLE CAME OFF WITH THE CAP. REP FROM MEDICAL OFFICE STATED WHEN REMOVING THE ORANGE NEEDLE CAPS, THE WHOLE NEEDLE COMES OFF WITH THE CAP. STATED THIS HAPPENED WITH 5 SYRINGES FROM THIS BOX. NO DIFFICULTY REMOVING THE NEEDLE SHIELD."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 SEPARATED FROM HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN REMOVING THE ORANGE NEEDLE CAPS, THE WHOLE NEEDLE CAME OFF WITH THE CAP. VERBATIM: REP FROM MEDICAL OFFICE STATED WHEN REMOVING THE ORANGE NEEDLE CAPS, THE WHOLE NEEDLE COMES OFF WITH THE CAP. STATED THIS HAPPENED WITH 5 SYRINGES FROM THIS BOX. NO DIFFICULTY REMOVING THE NEEDLE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306432 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9161986 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1