BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50 ML CATHETER TIP

    MDR report key: 14190075 · Received April 22, 2022

    Report

    Report Number
    1911916-2022-00212
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 30, 2022
    Report Date
    June 22, 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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 16-JUN-2022. H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE PLUNGER ROD IS BROKEN. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE PLUNGER ROD THUMB PRESS IS DAMAGED. THE THREE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE ASSEMBLY PROCESS INDUCING THE DAMAGE TO THE PLUNGER ROD. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303553, LOT NUMBER 1103488. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE ALIGNMENT OF THE RAILS AND CONVEYORS WAS GOOD, AND THE FLOW OF PRODUCT WAS ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM 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 BD SYRINGE 50 ML CATHETER TIP HAD A BROKEN PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE'S PLUNGER IS BROKEN."

    Description of Event or Problem · 0

    IT WAS REPORTED BD SYRINGE 50 ML CATHETER TIP HAD A BROKEN PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE'S PLUNGER IS BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171225 BD SYRINGE 50 ML CATHETER TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1103488

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown