BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 6MM INSULIN SYRINGES

    MDR report key: 15225630 · Received August 15, 2022

    Report

    Report Number
    1920898-2022-00547
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 19, 2022
    Report Date
    July 22, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1326750, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 22-NOV-2021. MEDICAL DEVICE LOT #: 1305908, MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2026, DEVICE MANUFACTURE DATE: 01-NOV-2021. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 1CC SYRINGES FILLED WITH APPROXIMATELY 50 UNITS OF A CLEAR LIQUID IN THE BARREL. CUSTOMER STATES THAT THERE WAS A BLACK FM INSIDE OF THE BARREL OF THE SYRINGE. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED A DARK PIECE OF MATERIAL ON THE STOPPER. ONE SAMPLE WAS FLUSHED OUT AND THE MATERIAL REMAINED ON THE STOPPER. THE REMAINING SAMPLE WAS NOT FLUSHED OUT. 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 POLYCARBONATE MIXED WITH SILICONE. SAMPLES WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) FOR FURTHER REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1326750. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200991544, 200991541, 200991375] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: EMBECTA 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 PRIOR TO USE WITH THE BD ULTRA-FINE¿ 6MM INSULIN SYRINGES A BLACK FM INSIDE OF THE BARREL OF THE SYRINGE. THIS WAS FOUND TWICE EACH IN LOTS 1326750 AND 1305908. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER SAID THAT THERE WAS A BLACK FM INSIDE OF THE BARREL OF THE SYRINGE, AND REQUESTED AN INVESTIGATION INTO THE EXACT SUBSTANCE OF WHAT IT WAS AND THE EXACT SIZE. PHOTO #1 - SINCE THE BLACK FM IS NOT EASILY VISIBLE IN THE DELIVERED PRODUCT, IT SEEMS THAT IT IS NECESSARY TO INSPECT THE COMPONENT AFTER SECURING THE FOREIGN MATERIAL THROUGH INTERNAL WASHING. PHOTO #2 - THE BLACK FM IS VISIBLE IN THE DELIVERED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302677 BD ULTRA-FINE¿ 6MM INSULIN SYRINGES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown