BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 13057033 · Received December 21, 2021

    Report

    Report Number
    1911916-2021-01283
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 24, 2021
    Report Date
    January 19, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: IT WAS REPORTED THE FLUSH IS BROKEN. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A SYRINGE WITH NO PACKAGING FLOW WRAP OR TIP CAP. THE SYRINGE BARREL HAS A CRACK. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM DURING THE PLUNGER ROD ASSEMBLY PROCESS INDUCING THE CRACK TO THE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306595, LOT NUMBER 1152464. 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 PLUNGER ROD ASSEMBLY STATION WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCT WAS GOOD. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE BARREL WAS BROKEN AND LEAKED FLUID DURING THE INJECTION. THIS OCCURRED WITH 14 SEPARATE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "DURING USE, IT WAS FOUND THAT THE FLUSH WAS BROKEN, AND THE FLUID FLOWED OUT DURING THE INJECTION".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE BARREL WAS BROKEN AND LEAKED FLUID DURING THE INJECTION. THIS OCCURRED WITH 14 SEPARATE SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DURING USE, IT WAS FOUND THAT THE FLUSH WAS BROKEN, AND THE FLUID FLOWED OUT DURING THE INJECTION"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949706 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1152464

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown