Catalog Number 5122-1220 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Distress (2329); Discomfort (2330); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/24/2016 |
Event Type
malfunction
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Manufacturer Narrative
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On (b)(6) 2016 incident occurred and was reported to qiagen technical service.On (b)(6) 2016 device was removed from patient without injury.On 07mar2016 device was received at qiagen for evaluation.Unused devices from the same kit box were also sent for evaluation.On 15mar2016 defective device was inspected side by side with an unused device.The affected device showed no evidence of going through the heat step in the assembly process.This heat step helps secure the brush head to the shaft.On 16mar2016 defective device returned to the supplier for further investigation.
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Event Description
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On (b)(6) 2016 qiagen received a report, (b)(4), from (b)(6) where the brush head became detached from the shaft and remained inside the patient's cervix.Due to the patient's narrow cervix, the doctor could not easily remove the brush with forceps.Two days later the brush was removed from the patient under anesthesia without causing injury.
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Manufacturer Narrative
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Final evaluation of the returned device concluded that a manufacturing step was missed.This defect is not likely to cause a serious adverse event.
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Event Description
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On 24feb2016 qiagen received a report, (b)(4), from (b)(6) where the brush head became detached from the shaft and remained inside the patient's cervix.Due to the patient's narrow cervix, the doctor could not easily remove the brush with forceps.Two days later the brush was removed from the patient under anesthesia without causing injury.
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Search Alerts/Recalls
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