BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE

    MDR report key: 8024474 · Received October 31, 2018

    Report

    Report Number
    1920898-2018-00807
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 29, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240672. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200713459, 200713528] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER ON NEEDLE TIP ON LOT # 7240672. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 1CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7240672. CUSTOMER STATES THAT A FIBER WAS FOUND ON THE TIP OF THE NEEDLE. ALL RETURNED SYRINGES WERE EXAMINED AND 2 OUT OF 10 SAMPLES EXHIBITED A TRANSLUCENT STRAND OF MATERIAL ON THE SURFACE OF THE CANNULA SHAFT. 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 POLYETHYLENE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240672. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200713459, 200713528] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. THIS FM LIKELY REPRESENTS WHAT WE CALL ¿ANGEL HAIR¿. THIS IS CREATED WHEN WE MOVE COMPONENTS FROM ONE LINE TO ANOTHER VIA THE TUBE ¿PEA SHOOTERS¿. THIS IS A PRESSURIZED TUBING TRANSPORT SYSTEM MADE OF POLYETHYLENE PLASTIC; AS THE COMPONENTS MOVE THROUGH THE PEA SHOOTERS, OCCASIONALLY SMALL FRAGMENTS OF THE PLASTIC TUBE ARE STRIPPED OFF AND FORM THIS ANGEL HAIR. IN THIS CASE, IT MOST LIKELY FOUND IT¿S WAY INTO THE SHIELD AND ULTIMATELY ONTO THE CANNULA. THERE ARE VARIOUS EFFORTS WITHIN THE PLANT TO TRY AND HELP REDUCE AND HOPEFULLY ELIMINATE THIS, HOWEVER, IT IS AN INHERENT PORTION OF THE PROCESS AT THIS TIME 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 A "FIBRE" WAS FOUND ON THE NEEDLE TIP OF THE BD ULTRA-FINE II (SHORT) SELF-CONTAINED INSULIN SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "FIBRE" WAS FOUND ON THE NEEDLE TIP OF THE BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE. 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 A "FIBRE" WAS FOUND ON THE NEEDLE TIP OF THE BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863104 BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7240672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other