BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE

    MDR report key: 17140562 · Received June 15, 2023

    Report

    Report Number
    1911916-2023-00407
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 24, 2023
    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

    E.1. INITIAL REPORTER PHONE #: (B)(6). H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE BARREL FLANGE WAS DAMAGED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PREFILLED SYRINGE WITH NO PACKAGING FLOW WRAP AND THE BARREL FLANGE DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THE INFEED SCROLL WAS MISALIGNED DURING THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306593, LOT 2040579. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE PHOTO WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE PLUNGER ROD WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: ON (B)(6) 2023, THE RESPONSIBLE NURSE CLOSED AND RINSED THE END OF THE CATHETER AFTER INTRAVENOUS INFUSION TREATMENT FOR THE PATIENT. WHEN USING THE PRE-FILLED CATHETER IRRIGATOR, SHE FOUND THAT THE CORE ROD WAS DAMAGED AND COULD NOT BE USED, SO SHE IMMEDIATELY REPLACED OTHER PRE-FILLED CATHETER IRRIGATORS WITHOUT CAUSING ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134720 BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 2040579

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown