BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7826608 · Received August 29, 2018

    Report

    Report Number
    1920898-2018-00650
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 28, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 3/10CC, 8MM SYRINGE. CUSTOMER STATES THAT FM WAS FOUND ON THE NEEDLE SURFACE AFTER INJECTION. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED HARD MATERIAL ON THE SURFACE OF THE CANNULA. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY ADHESIVE. SAMPLE WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) ON 17AUG2018 FOR FURTHER REVIEW. ON 06SEP2018, HOLDREGE RECEIVED ONE (1) LOOSE 0.3ML, 8MM SYRINGE FROM REPORTED BATCH# 6102656. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. PER FTIR ANALYSIS THE MATERIAL IS MOST LIKELY ADHESIVE. PROBABLE ROOT CAUSE IS LIKELY TO BE ADHESIVE SPLATTER ONTO THE O-RING, WHICH COULD THEN TRANSFER THE ADHESIVE ONTO THE CANNULA. THE O-RING IS UTILIZED TO EXERCISE THE CANNULA WITHIN THE BARREL TIP ONCE ADHESIVE HAS BEEN APPLIED TO THE BARREL. (B)(4) WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS ADHESIVE RUN-OVER AND IT'S ASSOCIATED ROOT CAUSE(S). BATCH# 6102656 WAS MANUFACTURED PRIOR TO INITIATION OF THIS CAPA. NO ADDITIONAL ACTIONS AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 6144772 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200641047] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR FOREIGN MATTER ON NEEDLE ON LOT # 6102656. BASED ON THE SAMPLES / 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEEDLE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE AFTER INJECTION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER WAS FOUND ON THE NEEDLE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE AFTER INJECTION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669536 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6102656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other