BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE CAP

    MDR report key: 23479825 · Received November 5, 2025

    Report

    Report Number
    1423507-2025-00130
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 13, 2025
    Report Date
    January 23, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403502378
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE IS PENDING RETURN. PHOTOS WERE PROVIDED AND REVIEW IS UNDERWAY. THE INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D2B: PRO CODES: DWM; PNG. G4: PMA / 510(K)#: K160450; K241946. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION, BUT SEVEN PHOTOGRAPHS WERE RECEIVED AND REVIEWED. DURING PHOTO REVIEW, A SECOND POUCH CONTAINED THE PRODUCT; HOWEVER, THE PACKAGING WAS OPEN, AND BASED ON IMAGE REVIEW, NO SEALING MARKS WERE EVIDENT ALONG THE POUCH EDGE. THE OBSERVED FAILURE MODE HAS BEEN CONFIRMED AS A SEAL INTEGRITY FAILURE. A FORMAL INVESTIGATION WAS OPENED TO FURTHER INVESTIGATE THESE DEFECTS TO ENHANCE PROCESS ROBUSTNESS AND PREVENT RECURRENCE. G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6 (ANNEX G ¿ COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INSPECTION OF IMPORTS, ONE PACKAGING WAS FOUND WITH THE PRODUCT INSIDE BUT WITH THE PACKAGING OPEN AND WITH NO INDICATION THAT IT HAD EVER BEEN SEALED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE ISSUE WAS IDENTIFIED UPON RECEIVING THE PRODUCTS. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INSPECTION OF IMPORTS, ONE PACKAGING WAS FOUND WITH THE PRODUCT INSIDE BUT WITH THE PACKAGING OPEN AND WITH NO INDICATION THAT IT HAD EVER BEEN SEALED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE ISSUE WAS IDENTIFIED UPON RECEIVING THE PRODUCTS. THERE WAS NO PATIENT INVOLVEMENT IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2551692 VALVE CAP APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001624837 10885403502378

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown