MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR; CANNULA HUMIDIFICTION SYSTEM

Catalog Number 2416

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

The customer alleges that during a heater trial, the circuit popped off of the column and the patient's oxygen level dropped however; there were no reports of patient injury or harm.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4), a visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not rec'd yet at our facility.The device history record of batch number (b)(4) that belong to catalog number 2416 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr showed that the product was assembled & inspected according to our specs.No corrective action can be established at this time without the device sample or picture available for eval.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.If the device sample becomes available at a later date this complaint will be re-opened.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.The received sample was connected to a concha neptune and it was tested for one hour in order to confirm the failure mode reported by the customer; however, no issues were found.The circuit remained connected to the column and did not "pop off" as reported in the complaint.Based on the investigation performed, the reported complaint could not be confirmed.No issues were found with the returned device.

Event Description

The customer alleges that during a heater trial, the circuit popped off of the column and the patient's oxygen level dropped, however; there were no reports of patient injury or harm.The patient's condition is reported as fine.

• Brand Name: HUDSON CORRUGATED COMFORT FLO REMOTE TEMP POR
• Type of Device: CANNULA HUMIDIFICTION SYSTEM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4791396
• MDR Text Key: 5801691
• Report Number: 3004365956-2015-00151
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 2416
• Device Lot Number: 74L1403294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• 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