BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ 10ML SYRINGE SALINE FLUSH

    MDR report key: 12747322 · Received November 3, 2021

    Report

    Report Number
    1911916-2021-01133
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED THE WHITE CAP WAS FOUND DEFORMED AND HAD SOME DIRT ON IT. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING FLOW WRAP AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE TIP CAP OF THE SAMPLE IS DAMAGED AND HAS SPOTS WITH DISCOLORATION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. THIS DEFECT COULD OCCUR IF THE SYRINGE WAS NOT PROPERLY PLACED IN THE STERILIZATION TRAY INDUCING THE DAMAGE AND DISCOLORATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT NUMBER 1082924. 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 STERILIZATION TRAY LOADING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE PARTS WERE BEING PLACED CORRECTLY. 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 REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ 10ML SYRINGE SALINE FLUSH CAP WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT THE WHITE CAP WAS FOUND DEFORMED AND HAD SOME DIRT ON IT.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT BD POSIFLUSH¿ 10ML SYRINGE SALINE FLUSH CAP WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT THE WHITE CAP WAS FOUND DEFORMED AND HAD SOME DIRT ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647101 BD POSIFLUSH¿ 10ML SYRINGE SALINE FLUSH SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1082924 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown