MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. FOLEY CATHETER WITH TEMPERATURE SENSOR; CATHETER, UPPER URINARY TRACT

Model Number	81-080408
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
When the baby's diaper was opened, the foley catheter was found cracked with the balloon deflated.The catheter had fallen apart.The product was being used to measure the patient's body temperature.
Additional Manufacturer Narrative
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.
Event or Problem Description
When the baby's diaper was opened, the foley catheter was found cracked with the balloon deflated.The catheter had fallen apart.The product was being used to measure the patient's body temperature.

• Brand Name: FOLEY CATHETER WITH TEMPERATURE SENSOR
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park; box 180-3006, 602 parkway; la aurora, heredia, 146 ; CS 146
• MDR Report Key: 8977597
• Report Number: 2320762-2019-00006
• Device Sequence Number: 16967717
• Product Code: EYC
• UDI-Device Identifier: 50749756045808
• UDI-Public: 50749756045808
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 81-080408
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1