BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8805123 · Received July 18, 2019

    Report

    Report Number
    1024879-2019-01228
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 3, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: SEX: FEMALE. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THERE WAS HEMOLYSIS OCCURRING WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3). IT WAS REPORTED BLOOD WAS SEEN "LIQUEFYING". ADDITIONAL INFORMATION PROVIDED BY INITIAL REPORTER: "CUSTOMER REPORTED FOR THE SECOND TIME , HAVE PROBLEMS WITH LOT 9080851. ALREADY HAD A CLAIM FOR THE SAME SITUATION. IT IS SENT TO YOU FOR THE SECOND TIME AND THE SAME TIME HAPPENS. THE CLIENT ALSO REPORTS TO THE SELLER AND HAS MENTIONED THE SAME." ADDITIONAL INFORMATION FROM CUSTOMER RECEIVED 2019-07-17: "Q:IS THE DATE OF THE INCIDENT KNOWN? A: APPROXIMATELY ON (B)(6) 2019. Q:WILL YOU PROVIDE MORE DETAILS ABOUT THE ISSUE YOU ENCOUNTERED? A:THE PROBLEM OCCURS WHEN THE TUBE IS INTRODUCED IN THE VACUTAINER. THE RUBBER IN THE NEEDLE IS MOVED TO THE SIDE LEAVING THE BLOOD TO THE VACUTAINER. Q:WAS THERE PATIENT INVOLVEMENT? A: YES. IF YES, PLEASE PROVIDE PATIENT IDENTIFIERS (I.E. GENDER, WEIGHT, ETHNICITY, ETC.) . FEMALE. Q:ARE SAMPLES OR PHOTOS AVAILABLE FOR INVESTIGATION? A:YES I HAVE PHOTOS. Q:WERE THERE ANY ADVERSE EVENTS DUE TO THE REPORT ISSUE? A:NO Q:SERIOUS INJURY? A: NO, JUST A BAD EXPERIENCE WHEN THEY SAW THE BLOOD. Q:ERRONEOUS RESULTS? A:NO. Q:COURSE OF TREATMENT CHANGED? A: NO. Q: EXPOSURE TO BLOOD/BODILY FLUID? A: NO. Q:MEDICAL INTERVENTION? A:NO. Q:OTHER ACTIONS? A: WE JUST TAKE OUT ALL NEEDLE BOXES OF THIS LOT WITH PROBLEM."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS HEMOLYSIS OCCURRING WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3). IT WAS REPORTED BLOOD WAS SEEN "LIQUEFYING". ADDITIONAL INFORMATION PROVIDED BY INITIAL REPORTER: "CUSTOMER REPORTED FOR THE SECOND TIME , HAVE PROBLEMS WITH LOT 9080851. ALREADY HAD A CLAIM FOR THE SAME SITUATION. IT IS SENT TO YOU FOR THE SECOND TIME AND THE SAME TIME HAPPENS. THE CLIENT ALSO REPORTS TO THE SELLER AND HAS MENTIONED THE SAME." ADDITIONAL INFORMATION FROM CUSTOMER RECEIVED 2019-07-17: "Q:IS THE DATE OF THE INCIDENT KNOWN? A: APPROXIMATELY ON (B)(6) 2019. Q:WILL YOU PROVIDE MORE DETAILS ABOUT THE ISSUE YOU ENCOUNTERED? A:THE PROBLEM OCCURS WHEN THE TUBE IS INTRODUCED IN THE VACUTAINER. THE RUBBER IN THE NEEDLE IS MOVED TO THE SIDE LEAVING THE BLOOD TO THE VACUTAINER. Q:WAS THERE PATIENT INVOLVEMENT? A: YES IF YES, PLEASE PROVIDE PATIENT IDENTIFIERS (I.E. GENDER, WEIGHT, ETHNICITY, ETC.) FEMALE. Q:ARE SAMPLES OR PHOTOS AVAILABLE FOR INVESTIGATION? A:YES I HAVE PHOTOS. Q:WERE THERE ANY ADVERSE EVENTS DUE TO THE REPORT ISSUE? A:NO. Q:SERIOUS INJURY? A: NO, JUST A BAD EXPERIENCE WHEN THEY SAW THE BLOOD. Q:ERRONEOUS RESULTS? A:NO. Q:COURSE OF TREATMENT CHANGED? A: NO. Q: EXPOSURE TO BLOOD/BODILY FLUID? A: NO. Q:MEDICAL INTERVENTION? A:NO. Q:OTHER ACTIONS? A: WE JUST TAKE OUT ALL NEEDLE BOXES OF THIS LOT WITH PROBLEM."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, 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 THAT THERE WAS HEMOLYSIS OCCURRING WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3). IT WAS REPORTED BLOOD WAS SEEN "LIQUEFYING". ADDITIONAL INFORMATION PROVIDED BY INITIAL REPORTER: "CUSTOMER REPORTED FOR THE SECOND TIME , HAVE PROBLEMS WITH LOT 9080851. ALREADY HAD A CLAIM FOR THE SAME SITUATION. IT IS SENT TO YOU FOR THE SECOND TIME AND THE SAME TIME HAPPENS. THE CLIENT ALSO REPORTS TO THE SELLER AND HAS MENTIONED THE SAME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599304 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 9080851 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other