Investigation summary an internal complaint (call (b)(4)) was received for a foley catheter with temperature sensor (part 81-080408) that was found cracked in a patient's diaper with the balloon deflated.The product was being used to monitor the patient's temperature.The defective sample was returned (b)(6) 2019 for evaluation.The silicone catheter portion of the device is manufactured by degania silicone.Therefore, a supplier corrective action request was sent to degania as well as the defective sample.As of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
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Root cause: the silicone catheter portion of the device is manufactured by degania silicone.Therefore, a supplier corrective action request (scar) was issued to degania.In its response, degania stated a root cause could not be determined.However, based on examination of the defective sample, it is possible the catheter malfunctioned as a result of improper treatment of the device during use (i.E.Excessive force during removal).Corrective action: in its scar response, degania stated no corrective actions are being taken at this time.Investigation summary: an internal complaint (b)(4) was received for a foley catheter with temperature sensor (part 81-080408) that was found cracked in a patient's diaper with the balloon deflated.The product was being used to monitor the patient's temperature.The defective sample was returned august 23, 2019 for evaluation.The returned sample confirmed the end user's complaint.The silicone catheter portion of the device is manufactured by degania silicone.Therefore, a supplier corrective action request was sent to degania as well as the defective sample.As of the date of this report, a response has not been received.A review of sales and similar complaint information showed that deroyal has sold (b)(4)cases of the finished good product from (b)(6) 2017 to present.During this review period, five complaints were received for the same product, which equates to a complaint-to-sales ratio of 0.032.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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