BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1 1/2 IN. SINGLE USE, STERILE, 18 G

    MDR report key: 13592331 · Received February 24, 2022

    Report

    Report Number
    1911916-2022-00104
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 24, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051961
    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

    IT WAS REPORTED THERE WAS DEBRIS WITHIN THE NEEDLE HUB. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED ON THE SAMPLE. INSPECTION INSIDE THE PACKAGING BLISTER AND THE PLASTIC BAG THE SAMPLE WAS RECEIVED IN WAS PERFORMED AND NO FOREIGN MATER WAS OBSERVED AS WELL. IN THE THREE PHOTOS PROVIDED, ONE PHOTO SHOWS THE PACKAGING BLISTER TOP WEB. THE OTHER TWO PHOTOS SHOW A NEEDLE ASSEMBLY WITH A BLACK SPOT AT THE BOTTOM PART OF THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED IN THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT NUMBER 1120195. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT THE PROBABLE ROOT CAUSE IS NOT KNOWN AS THE ACTUAL SAMPLE RECEIVED HAD NO FOREIGN MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE IS UNKNOWN. THE ACTUAL SAMPLE RECEIVED HAD NO FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ NEEDLE 1 1/2 IN. SINGLE USE, STERILE, 18 G FOREIGN MATTER WAS FOUND IN THE NEEDLE HUB. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305196 LOT#1120195 DATE OF INCIDENT: (B)(6) 2022. WHEN REMOVING SYRINGE FROM WRAPPER UNDER ISO5 CONDITIONS, THE PHARMACY TECHNICIAN NOTED DEBRIS WITHIN THE NEEDLE HUB, DID NOT USE THE PRODUCT, AND SAVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673624 BD¿ NEEDLE 1 1/2 IN. SINGLE USE, STERILE, 18 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305196 1120195 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown