BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 16 G

    MDR report key: 13875391 · Received March 24, 2022

    Report

    Report Number
    1911916-2022-00160
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 7, 2022
    Report Date
    March 25, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 08-FEB-2022. MEDWATCH REPORT #MW5107362.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305197 AND LOT NUMBER 1210583. 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. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 16 G A FOREIGN MATTER WAS FOUND IN THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   IT WAS REPORTED BY THE CONSUMER DEBRIS IN NEEDLE AND NEEDLE HUB. DATE OF EVENT- (B)(6). # OF OCCURRENCES - 1.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 16 G A FOREIGN MATTER WAS FOUND IN THE NEEDLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:   IT WAS REPORTED BY THE CONSUMER DEBRIS IN NEEDLE AND NEEDLE HUB. DATE OF EVENT- 07-FEB. # OF OCCURRENCES - 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802145 BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, 16 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305197 1210583 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown