Catalog Number IAB-06830-U |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that after a successful insertion of the iab, "the machine repeatedly alarmed and [the user] saw bleeding in the helium connection pipe.The machine was suspended.Remove the catheter and replace it with a new one to continue working".The 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported a "fine".
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Manufacturer Narrative
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Qn# (b)(4).The reported complaint that "bleeding in the helium connection pipe" was not able to be confirmed as the product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint was undetermined.No further action required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a; corrected data: n/a.
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Event Description
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It was reported that after a successful insertion of the iab, "the machine repeatedly alarmed and [the user] saw bleeding in the helium connection pipe.The machine was suspended.Remove the catheter and replace it with a new one to continue working".The 2nd iab was inserted at the same insertion site.No patient harm or injury.The patient status is reported a "fine".
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Search Alerts/Recalls
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