BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 8279736 · Received January 25, 2019

    Report

    Report Number
    1920898-2019-00108
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 3, 2019
    Report Date
    January 31, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (9) 3/10CC, 8MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 7100846. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7100846 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) QUALITY NOTIFICATIONS THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY RANKING IS S1. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING LIGHT/ILLEGIBLE ON LOT # 7100846. INVESTIGATION CONCLUSION: ALL RETURNED SYRINGES WERE EXAMINED AND ALL SCALE MARKINGS WERE OBSERVED TO BE CLEARLY AND LEGIBLY PRINTED WITHOUT INTERFERING WITH ADJACENT SCALE MARKINGS. ALSO, NO SMUDGES WERE OBSERVED ON THE BARREL. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. 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 BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLES HAD SCALES THAT WERE NOT PRINTED CLEARLY. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGES WITH THE BD ULTRA-FINE¿ NEEDLES HAD SCALES THAT WERE NOT PRINTED CLEARLY. THIS OCCURRED ON 10 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69875 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE 7100846 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other