BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, 28 FR RIGHT ANGLE

    MDR report key: 7915801 · Received September 27, 2018

    Report

    Report Number
    3011175548-2018-01047
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 13, 2018
    Report Date
    September 27, 2018
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    GBZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE THORACIC CATHETER WAS RECEIVED AND INSPECTED. THE BOTTOM SIDE OF THE CATHETER POUCH WAS FOUND TO BE UNSEALED. UPON FURTHER INSPECTION IT WAS DETERMINED THAT THERE WERE NO SIGNS THAT THE POUCH HAD BEEN ATTEMPTED TO BE SEALED. THERE WERE NO WITNESS LINES CREATED BY THE SEALER OR DEFORMATION OF THE FILM CAUSED BY THE HEAT OF THE SEALING PROCESS. THE PVC THORACIC CATHETERS ARE SUPPLIED TO ATRIUM BY A CONTRACT MANUFACTURER (DIVERSATEK HEALTHCARE), WHICH IS RESPONSIBLE FOR THE ASSEMBLY AND PACKAGING PROCESSES. ATRIUM RECEIVES THE PRODUCT AND PERFORMS AN AQL SAMPLING AND INSPECTION OF THE PACKAGED ASSEMBLY. THE INSPECTION INCLUDES VERIFICATION OF APPROPRIATE LABELING AND PACKAGING. REVIEW OF THE RECEIVING INSPECTION RECORDS FOR THIS LOT OF CATHETERS WERE FOUND TO HAVE MET SPECIFICATIONS. BASED ON THE CONFIRMATION OF THE COMPLAINT, ATRIUM MEDICAL HAS ISSUED A SUPPLIER CORRECTIVE ACTION REQUEST TO THE SUPPLIER OF THE CATHETERS. CLINICAL EVALUATION: THORACIC CATHETERS ARE STERILE, SINGLE USE, DISPOSABLE DEVICES AND ARE INTENDED TO FACILITATE THE EVACUATION OF AIR AND/OR FLUID FROM THE CHEST CAVITY OR MEDIASTINUM. A PACKAGE THAT IS UNSEALED WOULD BE EXPECTED TO BE NOTICED BEFORE IT WAS ENTERED INTO THE STERILE FIELD, AS IT WAS IN THIS CASE. IT WOULD REPRESENT A DELAY IN TREATMENT FOR THE PATIENT. THE INSTRUCTIONS FOR USE (IFU) STATES DO NOT USE IF THE DEVICE OR PACKAGING IS DAMAGED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF PERFORMING THE INVESTIGATION AND WILL SUBMIT THE FOLLOW-UP REPORT ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    REPORT RECEIVED STATED THAT THE MANUFACTURING SEAL FOR THE THORACIC CHEST TUBE CATHETER POUCH WAS FOUND TO BE UNSEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758136 CATHETER, 28 FR RIGHT ANGLE CATHETER, CHOLANGIOGRAPHY GBZ ATRIUM MEDICAL 8128 ME221275

    Patients

    Seq Age Sex Outcome Treatment
    1