COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813793009 |
Device Problems
Break (1069); Material Frayed (1262); Misassembled (1398); Misconnection (1399); Tear, Rip or Hole in Device Packaging (2385); Infusion or Flow Problem (2964)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According the reporter, the catheter was of lower quality material and crumpled guide wire.Some guides were thicker than the end of the catheter which needed to force.Catheter that broke on the second day of use (fracture) or broke the tips during introduction.The guide tip did not fit the needle.Low flow from the second day of use.The guide was too flexible and had impaired the tunneling.The internal volume of the sets was smaller than the other catheters.The catheter was too soft, making it difficult to introduce in obese patient or with subcutaneous fibrosis.The thinner dilator had no consistency and did not play the role of dilator in patient with more skin or subcutaneous resistance.It was also stated that device had a set of complaints that lead to low durability of catheters generating the need for frequent change and impairing the performance of the sessions and also the need to use heparin in all sessions, which many services dispute.The kit had no blade and syringe.Puncture needle was not sealed when connected to syringe with air inlet.The box had no lid and came closed with micropore.A bad cover that broke and loosen from the connection with silicone.Fragile packaging.Thermosensitive catheter material, which lead to catheter deformation with body temperature alone.There was no reported patient outcome.
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Search Alerts/Recalls
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