MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEONATE DUAL HEATED DUAL DRAIN; RESPIRATORY GAS HUMIDIFIER

Catalog Number 880-15KIT

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon receipt the device was visually examined for any damage that might have been caused from abuse/misuse/and/or subjected to any toxic environments that could cause physical or chemical damage to the device.The melted area of the expiratory circuit was identified and confirmed.Said area is approximately one (1) inch long and has a smear texture.A device history record review could not be conducted since the lot number was not provided.The instructions for use for this device were reviewed.The ifu warns the end user, "do not place tubing on patient's skin, do not cover tubing with sheets, blankets, towels, clothing, or other materials".All circuits are 100% functionally and visually inspected for proper operation at the time of manufacturing, so it is unlikely that this defect was present at that time.The complaint was confirmed based upon the sample received.However, the defect was discovered after being in use.Therefore, based upon the circumstances as reported in the complaint and the damage observed on the returned sample, operational context caused or contributed to this event.A corrective action is not required at this time.

Event Description

The customer alleges that the circuit melted during use on a patient.Reports no harm or injury to patient.

• Brand Name: HUDSON NEONATE DUAL HEATED DUAL DRAIN
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6072103
• MDR Text Key: 58929315
• Report Number: 3004365956-2016-00391
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 880-15KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2016
• 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