MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER WITH TEMPERATURE SENSOR; CATHETER, UPPER URINARY TRACT

Model Number 81-080408

Device Problems Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516); Material Integrity Problem (2978); Material Protrusion/Extrusion (2979); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (call (b)(4)) was received indicating that a wire was found protruding from a foley catheter near the external collection bag.Prior to this, the device was not reading a temperature.A sample was reported to be available and is expected to be returned.However, as of the date of this report, it has not been received.The work order was reviewed for discrepancies that may have contributed to the reported event.The work order showed that one catheter was rejected.However, this was due to the catheter being dirty, not for a protruding wire.The raw material and finished good inventory was checked.No non-conforming product was found.The catheter portion of the device is manufactured by (b)(4).Therefore, a supplier corrective action request (scar) was issued september 12, 2017, to (b)(4).A response is due october 25, 2017.As of the date of this report, that 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 Description

A wire was protruding from the foley catheter with temperature sensor where it would connect to the external collection bag.Prior to this, the temperature was no longer reading when connected to the monitor.

Manufacturer Narrative

Root cause: a supplier corrective action request was issued to the catheter manufacturer, degania silicone.In its scar response, degania stated the condition reported occurred following improper use of the catheter.Corrective action: due to the root cause determination, a corrective action has not been taken.An internal complaint (b)(4) was received indicating that a wire was found protruding from a foley catheter near the external collection bag.Prior to this, the device was not reading a temperature.A sample was received october 9, 2017, and forwarded to the catheter manufacturer, degania silicone, for evaluation and testing.In its scar response, degania indicated the returned sample had deformed thermocouple protruding from a torn catheter wall.Per the manufacturer, this condition occurs if the silicone shaft is strongly pulled and quickly released.Silicone returns its shape more quickly than the sensor wire inside, allowing the wire to deform and create bumps.The instructions for use for the device warns against pulling on the catheter.The work order was reviewed for discrepancies that may have contributed to the reported event.The work order showed that one catheter was rejected.However, this was due to the catheter being dirty, not for a protruding wire.The raw material and finished good inventory was checked.No non-conforming product was found.The catheter portion of the device is manufactured by degania silicone.Therefore, a scar was issued (b)(6) 2017, to degania.A response was received (b)(6) 2017.Preventive action: due to the root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A wire was protruding from the foley catheter with temperature sensor where it would connect to the external collection bag.Prior to this, the temperature was no longer reading when connected to the monitor.

• Brand Name: FOLEY CATHETER WITH TEMPERATURE SENSOR
• Type of Device: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 6916675
• MDR Text Key: 90152446
• Report Number: 2320762-2017-00012
• Device Sequence Number: 1
• Product Code: EYC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041416
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-080408
• Device Lot Number: 43865531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1