BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE W/ BD ULTRA FINE II NEEDLE

    MDR report key: 8691724 · Received June 12, 2019

    Report

    Report Number
    1920898-2019-00530
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 29, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908820011
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR PACKAGE PRINTING DEFECT (DUPLICATE LOT) ON LOT # 8113713. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A SHELF CARTON OF 1CC, 8MM, 31G SYRINGES FROM LOT # 8113713. CUSTOMER STATES THAT THE LOT IS NOT CLEAR. THE PHOTOS WERE EXAMINED AND EXHIBITED THE LOT NUMBER TO BE UNCLEARLY PRINTED ON THE SHELF CARTON. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8113713. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE IS THE BOX MAY HAVE BEEN FEED INCORRECTLY DURING STAMPING OF THE INFORMATION REQUIRED. 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 BD INSULIN SYRINGE W/ BD ULTRA FINE¿ II NEEDLE LOT NUMBER WAS NOT CLEAR ON THE LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NOT CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484560 BD INSULIN SYRINGE W/ BD ULTRA FINE II NEEDLE SYRINGE W/ NEEDLE FMF BD MEDICAL - DIABETES CARE 8113713 00382908820011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other