BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROPLET INSULIN SYRINGE 31G X 6MM 0.5ML

    MDR report key: 16314799 · Received February 7, 2023

    Report

    Report Number
    3014312726-2023-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    October 4, 2022
    Report Date
    January 17, 2023
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC.
    Product Code
    FMI
    UDI-DI
    05907996095599
    PMA / PMN Number
    K153537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION TO SOL-MILLENNIUM R&D DEPARTMENT RECEIVED 2PCS OF DEFECTIVE SAMPLES AND UNUSED SAMPLES OF COMPLAINED HTL/DROPLET 0.5ML INSULIN SYRINGE 31G X 6MM (U-100 INSULIN ONLY)(PE BAG), REF 6002, LOT 02107171 FOR EVALUATION.THE 2PCS OF DEFECTIVE SAMPLES HAVE BEEN VISUALLY CHECKED USING AN OPTICAL MICROSCOPE UNDER MAGNIFICATION 50X. IN ONE OF THEM IT IS POSSIBLE TO SEE A TRANSLUCENT FOREIGN MATERIAL INSIDE THE CANNULA LUMEN, WHILE IN THE OTHER ONE NO VISIBLE FOREIGN MATERIAL IS VISIBLE. THE FOREIGN MATERIAL PRESENT IN DEFECTIVE SAMPLE 1 WAS ANALYZED BY FTIR INFRARED SPECTROSCOPY, WHILE IT WAS NOT POSSIBLE TO ANALYZE THE FOREIGN MATERIAL PRESENT IN DEFECTIVE SAMPLE 2 DUE TO REDUCED QTY EXTRACTABLE. RISK STATEMENT: CLOGGED-CANNULA: THE OVERALL RISK ASSESSMENT, GIVEN THE SEVERITY ASSESSMENT OF S2-MINOR INJURY AND A PROBABILITY ASSESSMENT OF P2-LOW, THE FINAL RISK PRIORITY NUMBER IS ]4. RISK LEVEL OF THIS SPECIFIC HAZARD IS IN GREEN AREA/LOW RISK. DETACHED/LOOSE-CANNULA: THE OVERALL RISK ASSESSMENT, GIVEN THE SEVERITY ASSESSMENT OF S3-MODERATE INJURY AND A PROBABILITY ASSESSMENT OF P2-LOW, THE FINAL RISK PRIORITY NUMBER IS 6. RISK LEVEL OF THIS SPECIFIC HAZARD IS IN GREEN AREA/LOW RISK

    Description of Event or Problem · 0

    ON(B)(6)2022 HTL-STREFA REGISTERED A COMPLAINT FROM THE CUSTOMER (HTL-STREFA S.A. REF. NO.: (B)(6)2022). BELOW FULL DESCRIPTION OF THE NOTIFICATION: "PATIENT RECEIVED 3 BOXES OF DROPLET INSULIN SYRINGES 31G X 6MM 0.5ML FROM HUMANA WITH LOT NUMBER: 02107171. PATIENT IS FAIRLY NEW TO THE DROPLET BRAND AND HAS BEEN USING BD SYRINGES FOR ROUGHLY 20 YEARS. THE PATIENT CLAIMS THAT THE NEEDLES "HAVE NO HOLE IN THEM," SO THAT HE CANNOT DRAW INSULIN. HE HAS TRIED DRAWING WATER AS WELL, BUT HE WAS UNABLE TO. HE CLAIMS THAT WHEN HE PULLS THE PLUNGER BACK, THE NEEDLE TIP IS PULLED INTO THE SYRINGE. HE HAS HAD THIS ISSUE WITH 2 NEEDLES IN ONE OF THE BOXES. WE ARE SENDING 4 REPLACEMENT BOXES AS A COURTESY AND ARE EXPECTING SAMPLES." THE COMPLAINT WAS FORWARDED TO THE MANUFACTURER (B)(4). CUSTOMER SAMPLE WAS RETURNED TO HTL-STREFA S.A. ON (B)(6)2022 AND RE-SEND TO THE MANUFACTURER FOR THE FURTHER ANALYSIS. THE RESULTS OF THE RETAINED SAMPLE EVALUATION WAS PROVIDED ON (B)(6)2022 AS COMPLAINT OFFICIAL FINAL RESPONSE LETTER COMP(B)(4). THE ARCHIVAL SAMPLES EVALUATION DID NOT REVEAL ANY NONCONFORMITIES THAT COULD CONTRIBUTE TO ARISING COMPLAINED DEFECTS AND NO ANOMALIES FOUND ON BATCH DOCUMENTATION. THE RESULTS OF THE CUSTOMER SAMPLE EVALUATION WAS PROVIDED ON (B)(6)2023 AS COMP-(B)(4)_ADDENDUM. SAMPLE RECEIVED BY THE CUSTOMER CONFIRMED THE COMPLAINED ISSUE, CLOGGED-CANNULA. THE FTIR INFRARED SPECTROSCOPY ANALYSIS CONFIRM THE CLOGGED ELEMENT IS AN EXCESS OF SILICONE OIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126558 DROPLET INSULIN SYRINGE 31G X 6MM 0.5ML SYRINGE, HYPODERMIC NEEDLE FMI SOL-MILLENNIUM MEDICAL INC. 0.5ML, 31 X 6MM 02107171 05907996095599

    Patients

    Seq Age Sex Outcome Treatment
    1 Male