BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7331129 · Received March 12, 2018

    Report

    Report Number
    1920898-2018-00147
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 27, 2018
    Report Date
    April 2, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SEVERITY: S2; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLE BENT BEFORE USE AND THE 1ST RELATED COMPLAINT FOR NEEDLE BROKE DURING USE ON LOT # 7100846. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 3/10CC, 8MM SYRINGES. CUSTOMER STATES THAT THE NEEDLE BROKE OFF IN THE SKIN AND THE NEEDLE WAS BENT PRIOR TO USE. BOTH RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED A BENT CANNULA. THE REMAINING SAMPLE EXHIBITED A BROKEN CANNULA. MICROSCOPIC EXAMINATION OF THE RETURNED SAMPLE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE BROKEN HUB END, CRACKED ADHESIVE AND TUBING OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION). WHEN VIEWED TOGETHER, THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE ADHESIVE MADE THIS OBSERVATION MORE APPARENT. THE SHIELD WAS ALSO EXAMINED FOR ANY POSSIBLE SCRAPES OR CUTS RELATED BY CANNULA RECAPPING OR IMPROPER SHIELDING, HOWEVER NOTHING WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7100846 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200694473] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT AND BROKEN CANNULA). 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.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: 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 THAT DURING USE A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE MALFUNCTIONED AS ¿THE NEEDLE BROKE OFF IN CONSUMER¿S SKIN. THE NEEDLE WAS BENT PRIOR TO USE.¿ THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175774 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 7100846 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other