BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 14177815 · Received April 21, 2022

    Report

    Report Number
    9617032-2022-00406
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    April 11, 2022
    Report Date
    August 9, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH DRAWN WITH WATER, AND NO ISSUES WERE OBSERVED RELATING TO CLOGGED CANNULA AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOGGED CANNULA. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H.6. INVESTIGATION SUMMARY "MATERIAL #: 364314. LOT/BATCH #: 0203261. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH DRAWN WITH WATER, AND NO ISSUES WERE OBSERVED RELATING TO CLOGGED CANNULA AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE CLOGGED CANNULA. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE, THE DEVICE EXPERIENCED A CLOGGED BLOCKED CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BEFORE BLOOD COLLECTION, IT WAS FOUND THAT THE NEEDLE WAS CLOGGED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE, THE DEVICE EXPERIENCED A CLOGGED BLOCKED CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: BEFORE BLOOD COLLECTION, IT WAS FOUND THAT THE NEEDLE WAS CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2325947 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON AND COMPANY (BD) 0203261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown