BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 8340837 · Received February 14, 2019

    Report

    Report Number
    1920898-2019-00154
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 23, 2019
    Report Date
    February 22, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382904916015
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS FROM LOT # 7170874. CUSTOMER STATES THAT THERE IS AN EXCESS OF SILICONE WHICH GENERATES THE PEELING OF THE DISPLAY, BAR CODES, EAN CODES. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED EXCESS GLUE ON THE BOTTOM SURFACE OF THE SHELF CARTON WHICH COULD CAUSE THE SHELF CARTON TO BE TORN. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7170874 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. POSSIBLE ROOT CAUSE: EXCESS GLUE USED DURING FORMATION OF THE SHIPPING CARTON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD, "EXCESS OF SILICONE WHICH GENERATES THE PEELING OF THE DISPLAY, BAR CODES, AND EAN CODES." THIS OCCURRED ON 49000 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 A BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD, "EXCESS OF SILICONE WHICH GENERATES THE PEELING OF THE DISPLAY, BAR CODES, AND EAN CODES." THIS OCCURRED ON 49000 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135151 BD 0.3 ML INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7170874 00382904916015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other