BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OASIS

    MDR report key: 21501334 · Received March 2, 2025

    Report

    Report Number
    3011175548-2025-000002
    Event Type
    Malfunction
    Date Received
    March 2, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 26, 2025
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    KDQ
    UDI-DI
    00650862110012
    PMA / PMN Number
    K043140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    RELATED MDR¿S: 3011175548-2025-0000022, 3011175548-2025-0000020, 3011175548-2025-0000021 AND 3011175548-2025-0000024. THE USER REPORTED THAT A TOTAL OF FIVE (5) DRAINS WERE FOUND TO HAVE CRACKED HOUSING. THREE (3) OF THE DRAINS WERE USED ON PATIENTS AND THEY LEAKED, LEADING TO THE DISCOVERY. THE OTHER TWO (2) DRAINS WERE EXAMINED BEFORE BEING ATTACHED TO PATIENTS AND WERE ALSO FOUND TO BE DAMAGED. THE USER STATED THAT NO DAMAGE COULD BE FOUND ON THE PACKAGING THEY HAD REMAINING. A PICTURE OF ONE OF THE DRAINS WAS PROVIDED WHICH SHOWS A LARGE CRACK IN THE BOTTOM RIGHT CORNER OF THE DRAIN COVER. THREE OUT OF THE FIVE REPORTED DRAINS WERE RETURNED. ONE DRAIN WAS USED AND TWO DRAINS WERE NOT USED. ONE OF THE DRAINS THAT WAS NOT USED HAD A LOT NUMBER (513512) PROVIDED AND THE OTHER 4 DRAINS DID NOT HAVE ANY REFERENCE TO AN ASSOCIATED LOT NUMBER. THE UNUSED DRAIN (LOT 513512) THE WATER SEAL WAS NOT FILLED AND THE AMPOULE AND PATIENT LINE WERE STILL ATTACHED TO THE BACK OF THE DRAIN. NO SIGN OF PLEURAL FLUID WAS SEEN IN THE DRAIN. THE BOTTOM RIGHT CORNER WAS CRACKED AND THE INSIDE OF THE DRAIN WAS OPEN TO THE ATMOSPHERE. THE POUCH WAS ALSO EXAMINED FOR SIGNS OF PACKAGING DAMAGE. NO DAMAGE TO THE POUCH CORRESPONDING WITH THE DRAIN DAMAGE WAS IDENTIFIED. THE OTHER UNUSED DRAIN THAT WAS RETURNED DID NOT HAVE ITS STERILE POUCH OR PATIENT LINE. THE WATER SEAL WAS NOT FILLED AND THERE WAS NO SIGN OF PLEURAL FLUID. THE BOTTOM RIGHT CORNER OF THE DRAIN WAS CRACKED ALSO OPENING THE DRAIN TO THE ATMOSPHERE. THE DRAIN THAT WAS USED DID NOT HAVE EITHER ITS POUCH OR PATIENT LINE. ITS WATER SEAL WAS FILLED TO THE 2CM LINE AND THERE WAS TRACES OF A SMALL AMOUNT OF PLEURAL FLUID IN THE COLLECTION CHAMBER. A CRACK WAS ALSO NOTICED IN THE BOTTOM RIGHT CORNER OF THE DRAIN, OPENING IT TO THE ATMOSPHERE. THE TWO DRAINS THAT WERE NOT RETURNED IT CAN BE ASSUMED THAT THEY ALSO EXHIBITED THE SAME DAMAGE AS THE RETURNED DRAINS BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE MANUFACTURED LOT NUMBER (513512) AND NO ANOMALIES IN MANUFACTURING WERE IDENTIFIED. THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO THE DESIGN, MATERIALS OR EQUIPMENT. A RECURRING LOT NUMBER QUERY WAS CONDUCTED FOR THE PROVIDED LOT 513512 AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED. A HISTORICAL REVIEW WAS COMPLETED FOR NCR¿S AND THERE WERE NO ISSUES IDENTIFY THAT RELATE DIRECTLY TO THIS COMPLAINT. THE CAPA/CR HISTORICAL REVIEW IDENTIFIED ONE RELATED (B)(4) WHICH WAS RELATED TO STANDARD DEVIATION EXCURSIONS. A COMPLAINT HISTORY REVIEW IDENTIFIED SIX RELATED COMPLAINTS THAT WERE ALL ASSOCIATED WITH DRAIN DAMAGE, WHICH WAS DETERMINED TO BE RELATED TO SHIPPING/HANDLING. A RISK REVIEW FOUND THAT THE RISK MANAGEMENT DOCUMENTS FOR THIS PRODUCT ADEQUATELY ADDRESS THE REPORTED DEFECT AND THE SEVERITY AND ANTICIPATED OCCURRENCE LEVEL ARE APPROPRIATE. THE IFU PROVIDES ADEQUATE INSTRUCTIONS FOR THE SETUP AND USE OF THE DEVICE. THE IFU INSTRUCTS THE USER NOT TO USE THE DEVICE IF IT OR THE PACKAGING IS DAMAGED. BASED ON THE EVALUATION OF THE DEVICES, THE COMPLAINT IS CONFIRMED DUE TO THE IDENTIFIED DAMAGE TO THE BOTTOM RIGHT CORNER OF ALL 3 OF THE RETURNED DRAINS. BECAUSE THE DAMAGE TO ALL THREE DRAINS WAS IDENTICAL, IT CAN BE ASSUMED THE OTHER 2 THAT THE USER CLAIMED WERE DAMAGED EXHIBITED THE SAME DAMAGE. THE MOST LIKELY CAUSE OF THIS IS AN IMPACT TO THE SHIPPING BOX THE DRAINS WERE PACKAGED IN, COMPROMISING THE SEAL OF THE DRAIN. THE ROOT CAUSE IS SUPPLY CHAIN - HANDLING DAMAGE.

    Description of Event or Problem · 0

    REPORT RECEIVED FROM CUSTOMER THAT THEY HAD DRAINS THAT WERE OBSERVED TO HAVE A CRACKED HOUSING. THERE WAS NO VISIBLE PACKAGING DAMAGE DETECTED. THE DRAIN WAS NOTICED TO HAVE THE CRACKED HOUSING DURING USE WHEN THE DRAIN WAS CONNECTED TO THE PATIENT AND IT WAS DISCOVERED THAT DRAINAGE WAS LEAKING ON THE FLOOR. NO PATIENT INJURY OR HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695812 OASIS BOTTLE, COLLECTION, VACUUM KDQ ATRIUM MEDICAL CORPORATION 3600-100 00650862110012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.