Returned for evaluation was a bioflo port.As received, approximately 25cm of the catheter and connector were attached to the bioflo port.The port septum contained bio material {blood} inside.No visual defects were noted to the returned bioflo port.Functional testing was performed.The leak test of assembled device as received noted no leaks.The customer's complaint description of a leak in the port could not be confirmed.The port was pressurized with air at 50 psi and submerged in water.No leaks were detected.No manufacturing non-conformances were observed during sample review.A root cause for the reported leak cannot be determined.Based on the evaluation of the returned device (no leaks) the break down of the patient's skin around the body does not appear to be related to the port device or leakage of the fluids from the port device.The root cause for the skin erosion cannot be determined.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: labeling review: the dfu for this product contains the following precautions: precautions: carefully read and follow all instructions prior to use.Only licensed health care practitioners should insert, manipulate, and remove these devices.Intended use/ indications for use: the bioflo port with endexo technology, bioflo dual port with endexo technology and the bioflo port with endexo and pasv valve technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products.The device is also indicated for blood specimen withdrawal.Maintenance: to help prevent clot formation and catheter blockage, the bioflo port should be filled with sterile heparinized saline after each use.Bioflo ports with the pasv valve may be flushed and locked with either normal saline or heparinized saline per institutional protocol.If the port remains unused for long periods of time, the lock should be changed at least once every four weeks.Precaution: some patients may be hypersensitive to heparin or suffer from heparin induced thrombocytopenia (hit) and these patients must not have their port primed with heparinized saline.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).
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