MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HEATED WIRE CIRCUIT, ADULT; ADULT BREATHING CIRCUIT

Catalog Number 780-20

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the circuit melted near the cuff proximal to the patient trach mask connection.No patient injury reported.The condition of the patient is reported as fine.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The product was assembled and inspected according to specifications.The sample was received for analysis.A visual exam was performed and it was observed that the circuit was melted.The corrugated tubing was inspected and it was found that the heated wires were assembled incorrectly.They were not uniformly distributed along the corrugated tubing.The heated wires were disassembled in order to inspect the wires for resistance and length, and were found to be acceptable according to acceptance criteria.The heated wires were functionally tested and no issues were found.Based on the investigation performed, the reported complaint was confirmed.The heated wires were assembled incorrectly, which is what could have caused the melting of the corrugated tubing.As a corrective action, the personnel involved in the manufacturing process were notified about this issue and will be retrained on the work instruction to verify the heated wires are distributed uniformly.

• Brand Name: HUDSON HEATED WIRE CIRCUIT, ADULT
• Type of Device: ADULT 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4342614
• MDR Text Key: 5217495
• Report Number: 3004365956-2014-00418
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/24/2014

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: Other
• Device Catalogue Number: 780-20
• Device Lot Number: 02J0902058
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/20/2014
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1