BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11407564 · Received March 3, 2021

    Report

    Report Number
    1920898-2021-00257
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 5, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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 # 4210811 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 ON PACKAGING. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HAVING 2 BOXES OF SYRINGES WITH NO EXPIRATION DATES. ADVISED CONSUMER THAT THESE BOXES WOULD BE EXPIRED. LOT # 4210811 - FOR BOTH BOXES; CAT # 324910; DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HAVING 2 BOXES OF SYRINGES WITH NO EXPIRATION DATES. ADVISED CONSUMER THAT THESE BOXES WOULD BE EXPIRED. LOT # 4210811 - FOR BOTH BOXES. CAT # 324910. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301359 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 4210811 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1