BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINEI IV INSULIN SYRINGE

    MDR report key: 10131056 · Received June 8, 2020

    Report

    Report Number
    1920898-2020-00634
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 27, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294245
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A DEFAULT. (B)(4). INVESTIGATION SUMMARY: NO SAMPLES 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# 6123812. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THIS BATCH WAS MANUFACTURED BEFORE EXPIRATION DATES WERE PUT ON PACKAGING. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR LABEL INFORMATION MISSING (EXPIRATION DATE) ON LOT # 6123812. A REVIEW OF RISK MANAGEMENT 150RMN-0001-16 REVISION 13 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SYRINGE, LABEL INFORMATION MISSING (EXPIRATION DATE)) WAS CAPTURED AND ADDRESSED APPROPRIATELY. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOX OF BD MICRO-FINEI¿ IV INSULIN SYRINGES HAD NO EXPIRATION DATE PRINTED ON IT. THIS WAS NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST STATED SHE HAS 5 -6 BOXES OF THE BD INSULIN SYRINGES, ALL WITH THE SAME LOT # AND CATALOG # AND NONE OF THEM HAVE EXPIRATION DATES ON THEM. STATED SHE PROVIDED A CONSUMER WITH ONE BOX OF THESE SYRINGES AND THE CONSUMER RETURNED IT, STATING HE DID NOT WANT TO USE THIS BOX BECAUSE HE LOOKED THE PRODUCT UP ONLINE AND HE BELIEVES THEY EXPIRED IN 2016. ADVISED PHARMACIST OF HOW BD DETERMINES THE EXPIRATION DATE USING THE COPYRIGHT DATE, THE LOT # AND JULIAN DATE. PHARMACIST STATED THERE IS NO COPYRIGHT/TRADEMARK DATE OR MANUFACTURE DATE ON ANY OF THE BOXES. ADVISED PHARMACIST THAT THE LOT # MEANS THIS BOX WAS EITHER MANUFACTURED IN 2006 EXPIRING IN 2011 OR 2016 EXPIRING IN 2021."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590777 BD MICRO-FINEI IV INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 329424 6123812 30382903294245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other