BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CNV 22X1

    MDR report key: 8947021 · Received August 29, 2019

    Report

    Report Number
    9617032-2019-00982
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 10, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    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

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. ADDITIONALLY, THE EXACT LOT NUMBER FOR THE DEVICE IN QUESTION IS UNKNOWN; HOWEVER, 3 POTENTIAL LOT NUMBERS WERE PROVIDED. FOR EACH LOT NUMBER RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, BUT THE ISSUE RELATING TO FOREIGN MATTER ON THE CANNULA WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND A RELATED INCIDENT WAS IDENTIFIED. BASED ON THIS REVIEW, THE FAILURE MODE IS CONFIRMED. H3 OTHER TEXT: SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A NEEDLE CNV 22X1. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PROBLEM OBSERVED WITH BD VACUTAINER PRECISIONGLIDE 22G REF 360210 BD NEEDLES. WE NOTICED ON SEVERAL NEEDLES THE PRESENCE OF A BLACK DEPOSIT OR PARTICLES ON THE NEEDLE AT THE TIME OF UNCAPPING. THIS HAS BEEN OBSERVED ON AT LEAST 5 NEEDLES BY MY TEAM. UNFORTUNATELY, WE DID NOT IMMEDIATELY TRACE THE BATCH CONCERNED BUT WE DO NOT KNOW THAT IT IS "ONE OF THE FOLLOWING BATCHES: LOT 9050843 OR LOT 9023828 OR LOT 8262823". 5 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE POSSIBLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9050843. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-02-19. MEDICAL DEVICE LOT #: 9023828. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-01-23. MEDICAL DEVICE LOT #: 8262823. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-09-19. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A NEEDLE CNV 22X1. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PROBLEM OBSERVED WITH BD VACUTAINER PRECISIONGLIDE 22G REF 360210 BD NEEDLES. WE NOTICED ON SEVERAL NEEDLES THE PRESENCE OF A BLACK DEPOSIT OR PARTICLES ON THE NEEDLE AT THE TIME OF UNCAPPING. THIS HAS BEEN OBSERVED ON AT LEAST 5 NEEDLES BY MY TEAM. UNFORTUNATELY, WE DID NOT IMMEDIATELY TRACE THE BATCH CONCERNED BUT WE DO NOT KNOW THAT IT IS "ONE OF THE FOLLOWING BATCHES: LOT 9050843. OR LOT 9023828. OR LOT 8262823." 5 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742060 NEEDLE CNV 22X1 BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other