BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE

    MDR report key: 7965739 · Received October 15, 2018

    Report

    Report Number
    1920898-2018-00772
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 21, 2018
    Report Date
    November 2, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (18) 3/10CC, 8MM, 30G SYRINGES IN OPEN POLY BAGS FROM LOT # 7289879. CUSTOMER STATES THAT THE LINES ARE PRINTED INCORRECTLY, THE STOPPERS ARE DEFECTIVE, SHE HAS PROBLEMS WITH WITHDRAW CORRECT DOSE OF INSULIN, AND THERE ARE BLOOD SUGAR LEVEL ISSUES. ALL RETURNED SYRINGES WERE EXAMINED AND NO DEFECTIVE STOPPERS WERE OBSERVED. ALL SAMPLES WERE ALSO TESTED USING THE PLUG GAUGE AND ALL SCALE MARKING PLACEMENTS FELL WITHIN SPECIFICATIONS. ALL SAMPLES WERE ALSO TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. THE RETURNED PHOTOS WERE ALSO EXAMINED AND ONE PHOTO EXHIBITED A SYRINGE WITH A MISSING 0 UNIT MARKING. CAPA 162566 WAS INITIATED TO ADDRESS SUCH PRINTING ISSUES AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7289879 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING DEFECTIVE, DAMAGED STOPPER, VOLUMETRIC ACCURACY AND GLUCOSE LEVEL ON LOT # 7289879. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (MISSING SCALE MARKING). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DEFORMED STOPPER, VOLUMETRIC ACCURACY, GLUCOSE LEVEL). 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 IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE THERE WAS AN ISSUE WITH VOLUMETRIC INACCURACY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 WITH THE USE OF THE BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE THERE WAS AN ISSUE WITH VOLUMETRIC INACCURACY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804881 BD MICRO-FINE¿ INSULIN SYRINGE NEEDLE INSULIN SYRINGE FMI BD MEDICAL - DIABETES CARE 7289879

    Patients

    Seq Age Sex Outcome Treatment
    1 Other