MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONFORT FLO HUMIDIFICATION SYSTEM WITH; CANNULA HUMIDIFICTION SYSTEM

Catalog Number 2414

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2015

Event Type  malfunction  

Event Description

The customer alleges that the column was leaking and separated near the white taping around the column.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).The device sample was not returned for evaluation at the time of this report.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the concha column was separated from the tubing.No other issues were observed.Functional testing was performed and the sample was found to be out of specification.The reported complaint that the column was leaking and separated near the white tape around the column was confirmed through visual inspection of the returned sample.The concha column separated from the tubing.A dhr review could not be conducted since the lot number was not provided.The investigation found no evidence to suggest a manufacturing related cause, therefore, the root cause is undetermined.

Event Description

The customer alleges that the column was leaking and separated near the white taping around the column.No patient injury reported.

• Brand Name: HUDSON CONFORT FLO HUMIDIFICATION SYSTEM WITH
• Type of Device: CANNULA HUMIDIFICTION SYSTEM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4898339
• MDR Text Key: 6831748
• Report Number: 3004365956-2015-00189
• 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,company representati
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• 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