BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15250259 · Received August 18, 2022

    Report

    Report Number
    1920898-2022-00564
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 25, 2022
    Report Date
    October 4, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 18-AUG-2022. H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) LOOSE 0.5ML BD INSULIN SYRINGES. THE CUSTOMER REPORTED THAT THE NEEDLE SHIELDS WILL NOT COME AWAY FROM THE SYRINGE, AND ON ONE SYRINGE THE NEEDLE HUB REMOVED FROM THE SYRINGE. THE RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 SYRINGE FEATURED A DETACHED NEEDLE HUB/SHIELD ASSEMBLY ¿ NO DAMAGE TO THE BARREL TIP WAS OBSERVED. THE REMAINING 3 SYRINGES WERE TESTED TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 0.5 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS) AND THE FOLLOWING WAS OBSERVED: SAMPLE NUMBER SHIELD REMOVAL FORCE (LBS). SAMPLE 1 2.20, SAMPLE 2 2.56, SAMPLE 3 2.88. THE TESTED SAMPLES MEASURED WITHIN SPECIFICATION; NO HUB SEPARATION WAS OBSERVED ON THE TESTED SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2020067. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200994725] 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. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WITH ONE SYRINGE THE NEEDLE HUB REMOVED FROM SYRINGE, WHEN REMOVED NEEDLE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE HUB SEPARATED FROM THE DEVICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED WITH ONE SYRINGE THE NEEDLE HUB REMOVED FROM SYRINGE, WHEN REMOVED NEEDLE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2369389 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 2020067 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown