BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11248496 · Received January 28, 2021

    Report

    Report Number
    1920898-2021-00128
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 8, 2021
    Report Date
    March 1, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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# 4121600. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THIS WAS MANUFACTURED BEFORE EXPIRATION DATES WERE PRINTED ON PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328411 BATCH NO: 4121600. SPOUSE HAS ONE BOX OF INSULIN SYRINGES WITH NO EXPIRATION DATE. STATED THE BOX IS UNOPENED. ADVISED SPOUSE THIS PRODUCT BOX WOULD BE EXPIRED. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6), USA HAS BEEN USED AS A DEFAULT.  A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328411 BATCH NO: 4121600. SPOUSE HAS ONE BOX OF INSULIN SYRINGES WITH NO EXPIRATION DATE. STATED THE BOX IS UNOPENED. ADVISED SPOUSE THIS PRODUCT BOX WOULD BE EXPIRED. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144449 SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 4121600

    Patients

    Seq Age Sex Outcome Treatment
    1