Catalog Number CS-25802-E |
Device Problem
Insufficient Information (3190)
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Patient Problems
Reaction (2414); Bronchospasm (2598)
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Event Date 12/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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"during surgery on (b)(6), the patient had bronchospasm shock once the cvc was inserted.Because the acute allergic reaction happened during surgery, the delayed allergic reactions caused by other medication can be ruled out.Therefore, it was suspected that both fentanyl and chlorhexidine of the cvc coating could be the cause of acute bronchospasm shock.Because the patient continued injecting fentanyl on (b)(6) , it was speculated that the coating chlorhexidine of cvc was more likely to be the cause".
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Customer reports: "during surgery on 4th dec, the patient had bronchospasm shock once the cvc was inserted.Because the acute allergic reaction happened during surgery, the delayed allergic reactions caused by other medication can be ruled out.Therefore, it was suspected that both fentanyl and chlorhexidine of the cvc coating could be the cause of acute bronchospasm shock.Because the patient continued injecting fentanyl on 4th-5th dec, it was speculated that the coating chlorhexidine of cvc was more likely to be the cause".
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Search Alerts/Recalls
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