Catalog Number 383408 |
Device Problems
Break (1069); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/13/2016 |
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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It was reported that on the second day of infusion, the patient removed the suspect device from the back of the hand in the middle of the night.The nurse found the catheter broken after two hours.The patient had a ct scan of the arm but the brother catheter was not detected.
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Manufacturer Narrative
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Additional information added as follows: sex - female.Describe event or problem - this incident occurred in the department of neurology.The patient had suffered a stroke and was delirious.Blood was noted inside of the extension catheter after removal but the patient is not known to have an infectious disease.The patient has since been discharged from the hospital.Device evaluation: result - one actual used sample was returned for evaluation.A visual examination of the sample was performed and found the catheter was broken from the root of the catheter.This section of catheter was noted to have stretch marks.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6134279.This device was manufactured in july 2016.Conclusion - bd was able to confirm the customer's indicated failure mode.The returned sample broken catheter cross section has a tensile deformation.According to complaint information, the patient pulled out the device.Therefore, the probable root cause of this defect is patient stretching the device.
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Event Description
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This incident occurred in the department of neurology.The patient had suffered a stroke and was delirious.Blood was noted inside of the extension catheter after removal but the patient is not known to have an infectious disease.The patient has since been discharged from the hospital.
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Search Alerts/Recalls
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