BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM TW 10BAG 500 SLA

    MDR report key: 19973819 · Received August 13, 2024

    Report

    Report Number
    3024508819-2024-00268
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 19, 2024
    Report Date
    November 5, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION, AND INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST. COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. MOST LIKELY LIQUID CAME OUT OF THE SYRINGE IS MEDICAL GRADE SILICONE. MEDICAL GRADE SILOXANES (SILICONES) ARE SPECIALLY DESIGNED, PRODUCED AND PURIFIED TO MEET THE REQUIREMENTS OF THE MEDICAL INDUSTRY, ARE WELL TOLERATED, AND ARE AN INTEGRAL MATERIAL FOR MEDICAL AND PHARMACEUTICAL USE. THIS MATERIAL HAS AN ESTABLISHED HISTORY OF SAFE CLINICAL EXPERIENCE WITH SUBCUTANEOUS ADMINISTRATIONS OVER SEVERAL DECADES. THE SPECIFIC USE OF SILICONE IN THIS CASE, AS A BARREL AND STOPPER LUBRICANT. THESE LUBRICANTS HAVE BEEN TESTED AND QUALIFIED IN ACCORDANCE WITH ISO 10993 STANDARDS FOR THE BIOLOGICAL EVALUATION OF MEDICAL DEVICES AND THESE MATERIALS PRODUCED NO EVIDENCE OF ADVERSE TOXICOLOGICAL EFFECTS.¿ THE LOW VOLUME OF SILICONE MEASURED IN THE INSULIN SYRINGES DOES NOT POSE A CLINICAL RISK AND WOULD NOT IMPACT THE CARE OF DIABETIC PATIENTS USING SUCH SYRINGES. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER STATES THE FOLLOWING: TODAY I WENT TO USE ONE OF THE SYRINGES ON MY DAUGHTER WHO USES GH, I HAVE A HABIT OF, BEFORE ASPIRATING THE MEDICATION, REMOVING THE AIR CONTAINED IN THE SYRINGE (0.02ML), STILL UNUSED, AND WHEN I REMOVED THE AIR I NOTICED A LIQUID COMING OUT OF IT. I EXPECTED ONLY AIR TO COME OUT. I'VE BEEN DOING THIS FOR A LONG TIME. I WOULD LIKE TO KNOW WHAT COULD BE THE LIQUID THAT CAME OUT OF THE SYRINGE, AS IT HAD NEVER BEEN USED BEFORE. MATERIAL: BD ULTRA-FINE 0.3ML 6MM / 31G. LOT #: 4008010 C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093867 SYRINGE 0.3ML 31GA 6MM TW 10BAG 500 SLA SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324916 4008010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male