BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 8241818 · Received January 11, 2019

    Report

    Report Number
    9617032-2018-03307
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 20, 2018
    Report Date
    March 20, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 RETAIN SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE RETAIN PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. 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 · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER HAD AN ISSUE WITH UNDERFILL. THERE WERE MULTIPLE LOTS INVOLVED IN THIS INCIDENT WITH 5000 OCCURRENCES PER LOT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8110885, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-04-20. MEDICAL DEVICE LOT #: 8171679, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2018-06-20. MEDICAL DEVICE LOT #: 8232613, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2018-08-20. MEDICAL DEVICE LOT #: 8171680, MEDICAL DEVICE EXPIRATION DATE: 2021-06-30, DEVICE MANUFACTURE DATE: 2018-06-20. MEDICAL DEVICE LOT #: 8107797, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-04-17. MEDICAL DEVICE LOT #: 8075976, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2018-03-16. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER HAD AN ISSUE WITH UNDERFILL. THERE WERE MULTIPLE LOTS INVOLVED IN THIS INCIDENT WITH 5000 OCCURRENCES PER LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34375 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD COLLECTION NEEDLE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other