MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB, 60IN; BREATHING CIRCUIT

Catalog Number 780-18

Device Problems Leak/Splash (1354); Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2015

Event Type  malfunction  

Event Description

The customer alleges that the rt found the infant circuit with a leak from melted tubing.No report of pt injury or harm.

Manufacturer Narrative

(b)(4).It is unk if the device sample is available for eval.

• Brand Name: HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB, 60IN
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4595892
• MDR Text Key: 17575577
• Report Number: 3004365956-2015-00099
• Device Sequence Number: 1
• Product Code: CAG
• 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
• Report Date: 02/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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