MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER; INCENTIVE SPIROMETER

Catalog Number 8884717301

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2013

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the product had a defective base and it was leaking air.No report of a patient injury or delay in treatment.

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Per dhr (device history record) the product triflo ii incentive deep breathing exerc, lot#01j1200529 was manufactured on 10/09/2012.The dhr investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes were required.The complaint can not be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.Teleflex will continue to monitor and trend relating complaints.

• Brand Name: HUDSON TRIFLO II INCENTIVE DEEP BREATHING EXER
• Type of Device: INCENTIVE SPIROMETER
• Manufacturer (Section D): TELEFLEX MEDICAL; tecate ; MX
• Manufacturer (Section G): PROLONGACION MISION EUSEBIO; kino # 1316; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn ; p.o box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3767186
• MDR Text Key: 18866290
• Report Number: 3003898360-2014-00010
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8884717301
• Device Lot Number: 01J1200529
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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