BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 13982347 · Received April 1, 2022

    Report

    Report Number
    1920898-2022-00211
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 6, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 0.5ML BD INSULIN SYRINGES FROM LOT# 1200429. THE CUSTOMER REPORTED 2 SYRINGES WITH A MISSING NEEDLE PRIOR TO USE, AND A NEEDLE BROKE DURING USE. THE SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 1 SYRINGE FEATURED A NEEDLE HUB/SHIELD ASSEMBLY DETACHED FROM THE BARREL; NO DAMAGE TO THE BARREL TIP WAS OBSERVED ON THE SAMPLE. THE OTHER SYRINGE FEATURED A BROKEN CANNULA. MICROSCOPIC EXAMINATION OF THIS SYRINGE REVEALED CHARACTERISTICS SUCH AS RESIDUAL BENDS ON THE HUB-END OF THE FRACTURED CANNULA, AND OVALITY (DEFORMATION FROM THE NORMALLY CIRCULAR CROSS SECTION) ¿ REMOVAL OF THE EPOXY MADE THIS EVIDENT. WHEN VIEWED TOGETHER THESE ARE ALL INDICATORS OF BENDING/RE-STRAIGHTENING MODE OF FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1200429. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CANNULA BROKEN). BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (HUB SEPARATES). THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE CANNULA WAS BROKEN BY THE USER AFTER HANDLING THE SYRINGE. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS (HUB SEPARATES). H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED NEEDLE BROKE OFF IN LEFT-SIDE STOMACH DURING USE AND REMOVED BY THE CONSUMER, DID NOT SEEK MEDICAL ATTENTION.. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGE WITH THE BD ULTRA FINE¿NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE BROKE OFF IN LEFT-SIDE STOMACH DURING USE AND REMOVED BY THE CONSUMER, DID NOT SEEK MEDICAL ATTENTION.. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728618 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown