BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7495405 · Received May 8, 2018

    Report

    Report Number
    1024879-2018-00180
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 23, 2018
    Report Date
    October 22, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER ON THE NEEDLE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. 10/18/2018 UPDATE: EVALUATION OF THE CUSTOMER SAMPLES UNDER MAGNIFICATION WAS PERFORMED AND THE FOREIGN MATTER WAS IDENTIFIED TO BE PLASTIC FROM THE IV NEEDLE SHIELD. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER ON THE NEEDLE WITH THE INCIDENT LOT WAS OBSERVED. 10/18/2018 UPDATE: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 10/18/2018 UPDATE: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿PHLEBOTOMISTS AT KIDDERMINSTER HOSPITAL PHLEBOTOMY DEPARTMENT OUTPATIENTS KTC OPENED ECLIPSE NEEDLE AND DISCOVERED PARTICLES ON THE NEEDLE. SEVERAL OF THESE HAVE BEEN FOUND SO THEY HAVE BEEN QUARANTINED. THE NEEDLE IS UNUSED.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7345636; MEDICAL DEVICE EXPIRATION DATE: 2022-11-30; DEVICE MANUFACTURE DATE: 2017-12-11. MEDICAL DEVICE LOT #: 8005605; MEDICAL DEVICE EXPIRATION DATE: 2022-11-30; DEVICE MANUFACTURE DATE: 2017-12-11. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR FOREIGN MATTER ON THE NEEDLE WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER ON THE NEEDLE WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿PHLEBOTOMISTS AT KIDDERMINSTER HOSPITAL PHLEBOTOMY DEPARTMENT OUTPATIENTS KTC OPENED ECLIPSE NEEDLE AND DISCOVERED PARTICLES ON THE NEEDLE. SEVERAL OF THESE HAVE BEEN FOUND SO THEY HAVE BEEN QUARANTINED. THE NEEDLE IS UNUSED.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336109 BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other