BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 18027157 · Received October 29, 2023

    Report

    Report Number
    1213809-2023-01198
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    October 5, 2023
    Report Date
    January 26, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9053120- FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A HAIR IN THE NEEDLE. TO AID IN THE INVESTIGATION, ONE SAFETYGLIDE NEEDLE IN A PACKAGING BLISTER AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THERE IS A PIECE OF HAIR-LIKE FOREIGN MATTER PRESENT OUTSIDE OF THE FLUID PATH. FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED, AND THE SPECIMEN SHOWED A STRONG CORRESPONDENCE TO HUMAN HAIR. IN THE PHOTOS, THE FOREIGN MATTER COULD BE OBSERVED WRAPPED AND PLUGGED IN THE SHIELD OF THE NEEDLE. THE OBSERVED CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION AND ASSOCIATED WITH THE NEEDLE SUPPLIER PROCESSES. INFORMATION WAS REVIEWED BY THE NEEDLE SUPPLIER AND THE RESULT OF THEIR INVESTIGATION WAS INCONCLUSIVE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305916, LOT 2138366. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 2138366 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCHES. THIS DEFECT APPEARS TO BE OCCURRING AT OR BELOW ITS EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE HAD FOREIGN MATTER. THE FOLLOWIG INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I OPENED A NEW "STERTILE" 1INCH NEEDLE TO VACCINATE A STUDENT AND NOTICED A HAIR. INITIALLY I THOUGHT THE HAIR MAY BE MY OWN AND WENT TO PULL IT OFF AND DISCARD THE NEEDLE, BUT THE HAIR WAS THROUGH THE NEEDLE. I SET THE NEEDLE ASIDE TO FOLLOW UP WITH LATER, GOT A NEW NEEDLE AND CONTINUED WITH MY PATIENT CARE." INCIDENT OR PROBLEM INFORMATION: TYPE OF INCIDENT/PROBLEM: DEFECT (DETECTED BEFORE USE) LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE UNEXPECTED OR PROLONGED CARE? NO, FREQUENCY OF PROBLEM: FIRST TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138452 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2138366 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown