BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE 1.0ML 8MM 90 BX 450 MO

    MDR report key: 9718018 · Received February 17, 2020

    Report

    Report Number
    1920898-2020-00136
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 7, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282890
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BARREL DAMAGED/CRACKED AND THE 2ND RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE (NOT GETTING DOSE) ON LOT # 9063823. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED. 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. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9063823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200812920] NOTED FOR CRACKED BARREL. THERE WERE THREE (3) NOTIFICATIONS [200812809, 200813473, 200812377] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE 1.0ML 8MM 90 BX 450 MO HAD A CRACKED IN THE BARREL AND PATIENT DID NOT RECEIVE CORRECT DOSE OF INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE(S): CONSUMER FOUND 1 SYRINGE WITH CRACK IN BARREL AT THE 50 UNIT MARKER. CONSUMER NOTICED DURING HER INJECTION. FEELS DID NOT RECEIVE HER FULL DOSE. CONSUMER WILL JUST TEST AGAIN TO SEE WHERE HER GLUCOSE LEVEL ARE. LONG TIME DIABETIC. LOT #: 9063823A. ITEM #: 328289. DATE OF EVENT: (B)(6) 2020. DISCARDED SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179476 BD SYRINGE 1.0ML 8MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328289 9063823 00382903282890

    Patients

    Seq Age Sex Outcome Treatment
    1 Other