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Catalog Number IAB-S840C |
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 09/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "after a smooth insertion, the pump started to work, and after about 5 minutes of work, blood was found in the catheter's sterile protective sheath, and a large amount of blood leaked out of the sheath, the doctor can't resolve it.Finally, the problem was solved after replacing the catheter and sheath, which did not cause any obvious harm to the patient." the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
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Event Description
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It was reported that "after a smooth insertion, the pump started to work, and after about 5 minutes of work, blood was found in the catheter's sterile protective sheath, and a large amount of blood leaked out of the sheath, the doctor can't resolve it.Finally, the problem was solved after replacing the catheter and sheath, which did not cause any obvious harm to the patient." the catheter was removed and a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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Qn#(b)(4).The reported complaint for "blood leaked out of the sheath" is not able to be confirmed.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 is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.If the product is returned at a later date, a full investigation of the sample will be completed.Other remarks: n/a.Corrected data: n/a.
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Search Alerts/Recalls
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