MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON INCENTIVE SPIROMETER

Catalog Number 1750

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch number (b)(4) that belong to catalog number 1750 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.No corrective action can be established at this moment since the device sample and/or picture are not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The end-user alleges that the inward air-let appears to be blocked as air does not enter and lift the ball.No patient injury reported.

Manufacturer Narrative

(b)(4).One unit of catalog number 1750 (incentive spirometer) was received for analysis.A visual exam was performed and it was observed that the valve was incorrectly assembled.Functional testing was also performed and the sample failed due to the incorrect valve assembly.Based on the investigation performed, the reported complaint was confirmed.It was found that the valve on the sample was assembled incorrectly at the manufacturing facility.As a corrective action, new equipment will be implemented in the assembly process line to help to assure the correct assembly of the valve.This corrective action will be performed and implemented on july 22th, 2016.Also, as an immediate action, personnel involved in the manufacturing process was notified about this complaint.

Event Description

The end-user alleges that the inward air-let appears to be blocked as air does not enter and lift the ball.No patient injury reported.

• Brand Name: HUDSON INCENTIVE SPIROMETER
• Type of Device: INCENTIVE SPIROMETER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5413159
• MDR Text Key: 38117753
• Report Number: 3004365956-2016-00112
• Device Sequence Number: 1
• Product Code: BWF
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1750
• Device Lot Number: 74D1502238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• 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