BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE

    MDR report key: 8344144 · Received February 15, 2019

    Report

    Report Number
    1920898-2019-00161
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    February 4, 2019
    Report Date
    February 8, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903267255
    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

    (B)(6). 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 MISSING LABEL CONTENT (NO LOT) ON LOT # 8113627. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS FOR 1/2CC, 8MM, 30G SYRINGES FROM LOT # 8113627. CUSTOMER STATES THAT THERE IS NO LOT. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED SHELF CARTONS WITHOUT THE LOT NUMBER, MANUFACTURING DATE, AND EXPIRATION DATE PRINTED ON THE SHELF CARTON. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113617. ALL INSPECTIONS AND CHALLENGES 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. 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 WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 2 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135514 BD INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 8113627 00382903267255

    Patients

    Seq Age Sex Outcome Treatment
    1 Other