BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

    MDR report key: 8944364 · Received August 29, 2019

    Report

    Report Number
    1920898-2019-00882
    Event Type
    Injury
    Date Received
    August 29, 2019
    Date of Event
    August 1, 2019
    Report Date
    September 10, 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
    PO
    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# 5348743. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6172646. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 5047782. 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX HAS BEEN FOUND EXPERIENCING PATIENT-DEVICE INCOMPATIBILITY DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: INFLAMMATORY REACTION AFTER ADMINISTRATION OF A DRUG WITH ONE OF THE LOTS MENTIONED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5047782. MEDICAL DEVICE EXPIRATION DATE: 04/30/2020. DEVICE MANUFACTURE DATE: 02/16/2015. MEDICAL DEVICE LOT #: 5348743, MEDICAL DEVICE EXPIRATION DATE: 02/28/2021. DEVICE MANUFACTURE DATE: 12/14/2015. MEDICAL DEVICE LOT #: 6172646, MEDICAL DEVICE EXPIRATION DATE: 08/31/2021, DEVICE MANUFACTURE DATE: 06/20/2016.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX HAS BEEN FOUND EXPERIENCING PATIENT-DEVICE INCOMPATIBILITY DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: INFLAMMATORY REACTION AFTER ADMINISTRATION OF A DRUG WITH ONE OF THE LOTS MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737902 SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other