COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number 8813817009 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/13/2018 |
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 to the reporter, prior to use, it was stated that the arterial line was blocked.It was also stated that the catheter was not repaired, there was no leak, iodine solution was the cleaning agent used, tego was not utilized amd there was no luer adapter issue.There was no reported patient involvement.
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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 to the reporter, prior to use, it was stated that the arterial line was blocked.The flushing was performed prior to use and was successful.Nothing unusual was observed prior to use.It was also stated that the catheter was not repaired, there was no leak, iodine solution was the cleaning agent used, tego was not utilized and there was no luer adapter issue.Another catheter was used to resolve the issue.There was no reported patient involvement.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted that the guide wire wouldn't pass through the hub in the venous lumen.An engineering evaluation of the returned product noted found that one of the lumens was smaller than the other, which prevented the guide wire from passing through it.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.Occlusion of the venous lumen was caused by an excess of solvent during the manufacturing process.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.
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