MAUDE Adverse Event Report: TELEFLEX HUDSON NEONATE DUAL HEATED DUAL DRAIN; BREATHING CIRCUIT

Catalog Number 880-15KIT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the two limbs of the circuit melted together which created a leak in the circuit.No patient injury or harm reported.

Manufacturer Narrative

Three (3) pictures of catalog number 880-15kit (neonate dual heated dual drain) were received for analysis.They were visually inspected finding the corrugated tubing melted.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record (dhr) of batch number 02b1401846 was reviewed and no issues or discrepancies were found relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to our specifications.The customer complaint was confirmed based on the visual inspection of the received pictures.The pictures showed a melted section on the corrugated tubes, but the product ifu states several recommendations in order to avoid overheating.Based on this, it is not possible to determinate the root cause of the failure reported.If device sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON NEONATE DUAL HEATED DUAL DRAIN
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton,rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4121010
• MDR Text Key: 4943764
• Report Number: 3004365956-2014-00310
• 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: 07/15/2014

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: 880-15KIT
• Device Lot Number: 02B1401846
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONCHA NEPTUNE HEATER