BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 16652989 · Received March 30, 2023

    Report

    Report Number
    1024879-2023-00182
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 9, 2023
    Report Date
    May 1, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2152267. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027. DEVICE MANUFACTURE DATE: 01-JUN-2022. MEDICAL DEVICE LOT #: 2200223. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2027. DEVICE MANUFACTURE DATE: 19-JUL-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. THE NATURE AND ORIGIN OF THE FOREIGN MATTER COULD NOT BE DETERMINED FROM THE PHOTOS. ADDITIONALLY, 30 RETENTION SAMPLES OF EACH REPORTED LOT NUMBER (60 TOTAL) FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES OF FOREIGN MATTER WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR BOTH INCIDENT LOTS, 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 FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE "WHITE" FOREIGN MATTER IS ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CUSTOMER REPORTS THAT WHEN THE SHIELD IS REMOVED A WHITE OBJECT IS SEEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE "WHITE" FOREIGN MATTER IS ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CUSTOMER REPORTS THAT WHEN THE SHIELD IS REMOVED A WHITE OBJECT IS SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845626 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 SEE H.10 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown