BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 19973176 · Received August 13, 2024

    Report

    Report Number
    9617032-2024-01198
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643894
    PMA / PMN Number
    K202446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) INVESTIGATION SUMMARY: "MATERIAL #: 364389 LOT/BATCH #: 3151632 BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING IV SHIELD WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING IV SHIELD WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE MISSING IV SHIELD. 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."

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 14-AUG-2024. INVESTIGATION SUMMARY MATERIAL #: 364389. LOT/BATCH #: 3151632. BD RECEIVED 2 SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE INDICATED FAILURE MODE FOR MISSING IV SHIELD WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING IV SHIELD WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE MISSING IV SHIELD. 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 PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE, THE SYRINGE WAS MISSING ITS IV SHIELD RESULTING IN A CLEAN NEEDLE STICK INJURY TO THE USER. AN ADDITIONAL SYRINGE WAS FOUND WITHOUT AN IV SHIELD IN THE SAME SHELF CARTON. NO FURTHER IMPACT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING A BD PRESET¿ ECLIPSE¿ SYRINGE, THE SYRINGE WAS MISSING ITS IV SHIELD RESULTING IN A CLEAN NEEDLE STICK INJURY TO THE USER. AN ADDITIONAL SYRINGE WAS FOUND WITHOUT AN IV SHIELD IN THE SAME SHELF CARTON. NO FURTHER IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177194 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3151632 50382903643894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown