MAUDE Adverse Event Report: DEGANIA MEDICAL DEVICES PVT. LTD. FOLEY CATHETER, 400 SERIES 8 FRENCH; CATHETER, UPPER URINARY TRACT

Model Number	81-080408
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the device is manufactured for (b)(4) by (b)(4).A photograph of the defective device was sent to (b)(4) for evaluation, and the manufacturer determined that the root cause was the result of use error.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint (b)(4) was received for a foley catheter (finished good 81-080408, lot not provided) that contained a temperature probe wire that was protruding from the device.The device history record could not be reviewed because the lot number was not reported.Raw material and finished good inventory were checked and no non-conforming product was found.A sample was received from the customer for evaluation.Photos of the defective device were taken and sent to the manufacturer, (b)(4), for evaluation.The vendor determined that the catheter was pulled strongly, stretching the silicone shaft and thermocouple wire, which caused the deformation.A supplier corrective action request was issued to (b)(4).A response has been received.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The temperature probe wires were protruding from the catheter, which placed the patient at risk for significant urethral injury.The catheter was removed and replaced, and there was no patient harm.

• Brand Name: FOLEY CATHETER, 400 SERIES 8 FRENCH
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEGANIA MEDICAL DEVICES PVT. LTD.; 275 & 251 sec-6 imt manesar; gurgaon, haryana 12205 0; IN 122050
• MDR Report Key: 8116868
• Report Number: 2320762-2018-00012
• Device Sequence Number: 16566941
• Product Code: EYC
• UDI-Device Identifier: 00749756045803
• UDI-Public: 00749756045803
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 11/29/2018

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: 11/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1