MAUDE Adverse Event Report: DEROYAL INDUSTRIES FOLEY CATHETER WITH TEMPERATURE SENSOR; CATHETER, RETENTION TYPE, BALLOON

Catalog Number 81-080408

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

There is a temperature variation between the esophageal and the foley catheter.The esophageal is measuring 36 degrees as a baseline and the foley catheter is registering between 32-35 degrees.

Manufacturer Narrative

Investigation findings: the work order was reviewed for discrepancies that would have contributed to the reported issue.No discrepancies were identified.In addition to the work order review, the qfi report was evaluated for sales and similar complaints.(b)(4) and no reports were received to the reporting customer filling two reports in 2015.Lot mapping was performed and the raw material contained within the finished good was identified.Raw material (b)(4) and multiple lot numbers.The raw material is supplied to deroyal by (b)(4), but the internal components that detect temperature are manufactured at deroyal cientifica, (b)(4).A joint investigation was requested for (b)(4).Samples of the reported finished good lot number was obtained and forwarded to (b)(4).These samples have been forwarded to (b)(4) for functionality testing.At the time of the investigation completion, the results of the functional testing have not been received.In an email communication that was received from the vendor contact on (b)(6) 2015, it is stated "regarding the controls, we test our tscs 100% for correct temperature reading".The referenced email communication will be maintained with the qc complaint specialist email file.The qc complaint specialist followed up with the deroyal sales rep on (b)(6) 2015 in an effort to obtain add'l info for the complaint.It has been confirmed that the two complaints received from the reporting customer were isolated to a single operating suite.A response was received on (b)(6) via email stating, "no more issues since they replaced the cable with the deroyal cable.I did ask if them if the cable they were using before was a deroyal cable and they said, 'no'.I asked them if they saved it and they said they threw it away.As far as the machine being used and other types of electrical devices, we discussed briefly, he did not know the exact cause of the machine nor all the electrical devices being used in the room.He said if another occurrence were to happen, he would provide us with that info".The referenced email communication will be maintained within the qc complaint specialist email file.

• Brand Name: FOLEY CATHETER WITH TEMPERATURE SENSOR
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): DEROYAL INDUSTRIES; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4791401
• MDR Text Key: 5799822
• Report Number: 2320762-2015-00013
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/19/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 81-080408
• Device Lot Number: 37047857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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