BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

    MDR report key: 8550327 · Received April 25, 2019

    Report

    Report Number
    1024879-2019-00770
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Date of Event
    April 3, 2019
    Report Date
    June 13, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 MODES FOR OPEN PACKAGING AND FOREIGN MATTER ON THE PACKAGING WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOTS 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 OPEN PACKAGING AND FOREIGN MATTER ON THE PACKAGING WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. 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 BEFORE USE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THE SEAL INTEGRITY IS COMPROMISED WITH A FOREIGN MATTER ON THE PACKAGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE RECEIVED A LOT OF ECLIPSE PRE-ASSEMBLED, REF. 368650, NON-COMPLIANT ON THE DELIVERY OF OUR ORDER 46/19. THE BLISTERS ARE NOT SEALED, THIS CONCERNS THE LOT NO. 8318897 AND WE HAVE A BLISTER SEALED BUT WITHOUT PRE-MOUNTED INSIDE. ON A CARDBOARD WE HAD A SHEET, WHICH I ALSO JOIN YOU. IN TOTAL WE HAVE PUT ASIDE 88 ECLIPSES PRE-MOUNTED NON-COMPLIANT, WHICH WE LEAVE AT YOUR DISPOSAL IF NEEDED. THE DELIVERY OF THE ORDER 50/19, LOT 8250909, WE HAVE A PRE-ASSEMBLED ECLIPSE THAT HAS BEEN SEALED WITH OIL OR GREASE MAYBE?

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8318897, MEDICAL DEVICE EXPIRATION DATE: 2021-11-30, DEVICE MANUFACTURE DATE: 2018-12-10. MEDICAL DEVICE LOT #: 8250909, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2018-09-07. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THE SEAL INTEGRITY IS COMPROMISED WITH A FOREIGN MATTER ON THE PACKAGE. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WE RECEIVED A LOT OF ECLIPSE PRE-ASSEMBLED, REF. 368650, NON-COMPLIANT ON THE DELIVERY OF OUR ORDER 46/19. THE BLISTERS ARE NOT SEALED, THIS CONCERNS THE LOT NO. 8318897 AND WE HAVE A BLISTER SEALED BUT WITHOUT PRE-MOUNTED INSIDE. ON A CARDBOARD WE HAD A SHEET, WHICH I ALSO JOIN YOU. IN TOTAL WE HAVE PUT ASIDE 88 ECLIPSES PRE-MOUNTED NON-COMPLIANT, WHICH WE LEAVE AT YOUR DISPOSAL IF NEEDED. THE DELIVERY OF THE ORDER 50/19, LOT 8250909, WE HAVE A PRE-ASSEMBLED ECLIPSE THAT HAS BEEN SEALED WITH OIL OR GREASE MAYBE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343823 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other