Catalog Number MXA231X20X16V |
Device Problem
Insufficient Information (3190)
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Patient Problems
Fever (1858); Patient Problem/Medical Problem (2688)
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Event Date 05/01/2019 |
Event Type
malfunction
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Event Description
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Information was received that while a smiths medical central venous catheter was in use, patient had symptoms such as high fever and wound suppuration.Upon removal of the device, the symptoms had disappeared.No further adverse effects have been reported.
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Event Description
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Information was received stating devices were sealed prior to opening.Customer stated it is unclear whether sterile field was broken while device was in use, or if protocols for a sterile field were in place.The symptoms of the patient disappeared following extubation, and the patient is recovering well.Because the devices were extubated, this will now be reported as an averse event.
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Manufacturer Narrative
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Corrected information: the file was inadvertently marked reportable.The event reported under mfr 3012307300-2019-04973 was determined to be not reportable and no further reports will be filed using this file number.The device is not approved for distribution in the u.S.And is not similar to a product approved for distribution in the u.S.
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Search Alerts/Recalls
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