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Model Number 21-8466-24 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/04/2022 |
Event Type
malfunction
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Event Description
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Port was placed in operating room (or).Interventional radiology (ir) did a port check after the clinic noticed leaking when injecting saline after accessing.During the dye study we noticed the port was leaking internally.When operating room removed the port the next day to replace with a new device, the radiologist checked to see where the leak was coming from.The back of the metal port is leaking.Medication was pooling in patient's chest.Port was removed and replaced in a second surgery for the patient.Removal and replacement surgery were successful.Product was removed from use.Hospital has retained the product and has reached out to the manufacturer for awareness.
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Event Description
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Port was placed in operating room (or).Interventional radiology (ir) did a port check after the clinic noticed leaking when injecting saline after accessing.During the dye study we noticed the port was leaking internally.When operating room removed the port the next day to replace with a new device, the radiologist checked to see where the leak was coming from.The back of the metal port is leaking.Medication was pooling in patient's chest.Port was removed and replaced in a second surgery for the patient.Removal and replacement surgery were successful.Product was removed from use.Hospital has retained the product and has reached out to the manufacturer for awareness.
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Event Description
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Port was placed in operating room (or).Interventional radiology (ir) did a port check after the clinic noticed leaking when injecting saline after accessing.During the dye study we noticed the port was leaking internally.When ir removed the port the next day to replace with a new device, the radiologist checked to see where the leak was coming from.The back of the metal port is leaking.Medication was pooling in patient's chest.Port was removed and replaced in a second surgery for the patient.Removal and replacement surgery were successful.Product was removed from use.Hospital has retained the product and has reached out to the manufacturer for awareness.
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Search Alerts/Recalls
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