BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11369584 · Received February 23, 2021

    Report

    Report Number
    1920898-2021-00212
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 21, 2021
    Report Date
    April 27, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282913
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 BATCHS # 5173639 AND 5292670 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THE BATCHS WERE MANUFACTURED BEFORE EXPIRATION DATES WERE PUT ON PACKAGING. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE BOXES FROM LOT 5292670, AND 1 BOX FROM 5173639 WERE MISSING THE EXPIRATION DATE ON THEIR LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD INSULIN SYRINGE 8MM 31G 3/10. A TOTAL OF 4 BOXES ARE MISSING THE EXPIRATION DATE".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5292670. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2015-10-28. MEDICAL DEVICE LOT #: 5173639. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2015-08-06. 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 3 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE BOXES FROM LOT 5292670, AND 1 BOX FROM 5173639 WERE MISSING THE EXPIRATION DATE ON THEIR LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD INSULIN SYRINGE 8MM 31G 3/10 A TOTAL OF 4 BOXES ARE MISSING THE EXPIRATION DATE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266626 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328291 SEE SECTION H.10. 00382903282913

    Patients

    Seq Age Sex Outcome Treatment
    1