BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 13334051 · Received January 24, 2022

    Report

    Report Number
    1911916-2022-00018
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 3, 2022
    Report Date
    January 10, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE 50ML SYRINGE IS LEAKING BELOW THE RUBBER STOPPER. TO AID IN THE INVESTIGATION, ONE VIDEO AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE VIDEO SHOWS A 50ML SYRINGE WITH A RED SUBSTANCE IN IT. THERE IS A RED DROPLET PAST THE STOPPER. HOWEVER, WHEN THE PLUNGER IS PULLED PAST THE 50ML MARK THIS DEFECT CAN OCCUR. THE SYRINGE WAS REDESIGNED FROM 60ML TO 50ML TO MITIGATE THE LEAKAGE PAST STOPPER SYMPTOM. IN THE VIDEO THE PLUNGER APPEARS PULLED PAST THE 50ML MARK. THE TWO PHOTOS SHOW THE PACKAGING BLISTER TOP WEB. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303552, LOT NUMBER 1013550. 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 VIDEO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ SYRINGES LEAKED CHEMOTHERAPY MEDICINE PAST THE STOPPER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "IT WAS REPORTED THAT THE 50 ML SYRINGE IS LEAKING BELOW THE PLUNGER RUBBER. (STOPPER) THEY HAVE ALREADY IDENTIFIED 03 SYRINGES FROM THE SAME BATCH WITH THIS DEVIATION. SYRINGES THAT LEAKED ARE NOT AVAILABLE FOR COLLECTION, AS THEY WERE USED IN THE HANDLING OF CHEMOTHERAPY" "WAS INCIDENT NOTICED PRIOR, DURING OR AFTER USE? R: DURING THE USE OF THE SYRINGE; WAS THERE ANY DAMAGE TO PATIENT AND/OR HEALTH PROFESSIONAL? R: THERE WAS NONE. THE INCIDENT WAS NOTICED IN THE COMPARTMENT DURING MANIPULATION OF THE CHEMOTHERAPY MEDICATION. THE HEALTH PROFESSIONAL WAS PROPERLY USING PPE. WAS MEDICAL OR SURGEON INTERVENTION REQUIRED? R: NO. WAS THERE EXPOSURE OF CHEMOTHERAPY MEDICATIONS TO MUCOUS OR SKIN? R: NO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833657 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1013550

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown