BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 5/8IN

    MDR report key: 11182216 · Received January 15, 2021

    Report

    Report Number
    3002682307-2021-00016
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    November 24, 2020
    Report Date
    March 19, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-02-10. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 200109. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE PROVIDED PICTURE SAMPLE DISPLAYED THE REPORTED FOREIGN MATTER; HOWEVER, THE RETURNED SAMPLES CONSISTED OF SEVERAL BD VENFLON PRO SAFETY PRODUCTS, WHICH ARE NOT THE DEVICE REPORTED WITHIN THIS INCIDENT. THEREFORE, THE PHYSICAL SAMPLES RETURNED DID NOT ASSIST IN THE INVESTIGATION OF THIS ISSUE. THROUGH EXAMINATION OF THE PICTURE, A BLUE PARTICLE WAS OBSERVED WITHIN THE PRODUCT PACKAGING. IT IS POSSIBLE THAT THE PARTICLE RESULTED FROM THE WIPES USED FOR CLEANING PURPOSES WITHIN THE FACILITY. THIS PRODUCT IS ASSEMBLED AND PACKAGED WITHIN AN ENVIRONMENTAL CONTROLLED ROOM TO REDUCE THE RISK OF FOREIGN MATTER. BASED ON THE STRINGENT PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 25GA 5/8IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN OBJECT ON LUER. INCIDENT DESCRIPTION STATED: OPENED AN ORANGE NEEDLE AND NOTICED SOMETHING BLUE ON THE RIM OF THE OPENING OF THE CONNECTION PART OF THE NEEDLE. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NO INJURY - NOT USED. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER): NOT USED - SAVED FOR INVESTIGATION AND OTHER NEEDLES FROM SAME LOT QUARANTINED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 25GA 5/8IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN OBJECT ON LUER. INCIDENT DESCRIPTION STATED: OPENED AN ORANGE NEEDLE AND NOTICED SOMETHING BLUE ON THE RIM OF THE OPENING OF THE CONNECTION PART OF THE NEEDLE. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NO INJURY - NOT USED. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER): NOT USED - SAVED FOR INVESTIGATION AND OTHER NEEDLES FROM SAME LOT QUARANTINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77707 NEEDLE 25GA 5/8IN NEEDLE FMI BECTON DICKINSON, S.A. 200109

    Patients

    Seq Age Sex Outcome Treatment
    1