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Model Number MIDP95ADS |
Device Problem
Leak/Splash (1354)
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Patient Problems
Pain (1994); Swelling/ Edema (4577)
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Event Date 01/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated.Currently waiting for additional information regarding the incident and for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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(b)(6) 2024 patient resented w/ cp/sob, ct chest ordered after dual port accessed, felt popping sensation w/ injection- of contrast, imaging w/ contrast in left chest sq tissue, evaluated by radiologist and confirmed needle placement and blood return.Port de-accessed d/t pain/ edema around port pocked.Re-accessed on (b)(6) 2024 w/tissue displacement w/ flushing upper lumen via huber needle.(b)(6) 2024 procedure exchange.Port body on the back table: accessed upper port w/ bulging of the reservoir and leaking of saline on the underside of the port body.
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Manufacturer Narrative
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One dual port was returned for evaluation with approximately 1/5 cm of lumen attached.Visual inspection revealed multiple nicks and deep gouges on one side of the port, as well as multiple nicks on the top of the port body.These marks are indicative of "missing" the septum with the needle.A functional test was conducted by clamping one end of the lumen and attempting to flush the port with a huber needle.No leaks were noted.No lot number was provided.Without the lot number a review of the manufacture records for this device is not possible.Returned device functioned as intended.The device was further reviewed by medcomp engineering.As the returned device presented with no leaks when tested, it is suspected that the multiple deep gouges may suggest that fluids were injected believing the needle was in the port when it was actually alongside the port, thus giving the impression of a leak.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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