BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA NO INS

    MDR report key: 8879618 · Received August 9, 2019

    Report

    Report Number
    1920898-2019-00790
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 26, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903294084
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR ADHESIVE SPLATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 31GA NO INS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329408 BATCH NO.: 7240986, UNKNOWN. WHEN MOVING THE PLUNGER OUTSIDE OF VIAL BEFORE DRAWING UP INSULIN, PRESSES TO THE TOP THE PLUNGER AND WHITE STUFF COMES OUT OF NEEDLE. THE PLUNGER ROD HAS A REST POSITION OF 2 UNITS. UNKNOWN OCCURRENCE DATE. FOUND THIS WHITE STUFF COMING OUT OF NEEDLE ON 6 OTHER PRIOR BOXES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7240986. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2017-10-26. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5 ML 31GA NO INS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329408, BATCH NO.: 7240986, UNKNOWN. WHEN MOVING THE PLUNGER OUTSIDE OF VIAL BEFORE DRAWING UP INSULIN, PRESSES TO THE TOP THE PLUNGER AND WHITE STUFF COMES OUT OF NEEDLE. THE PLUNGER ROD HAS A REST POSITION OF 2 UNITS. UNKNOWN OCCURRENCE DATE. FOUND THIS WHITE STUFF COMING OUT OF NEEDLE ON 6 OTHER PRIOR BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672986 SYRINGE 0.5ML 31GA NO INS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10 00382903294084

    Patients

    Seq Age Sex Outcome Treatment
    1 Other