MAUDE Adverse Event Report: TELEFLEX HUDSON POCKET PEAK FLOW METER

Catalog Number 1801

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

The complaint is reported as: the customer alleges that the pocket peak flow meter is giving an inaccurate reading.The pt's condition is reported as fine.

Manufacturer Narrative

The sample was not available for eval, therefore, the complaint could not be confirmed.Based on similar complaints in the past, however, a capa was opened by the vendor of the pocket peaks to address the issue with inaccurate readings.The vendor also reported that additional checks were made on the mold in late 2013, and it was verified that the assembly process was not changed or modified.Prior to release, the units must meet mfg criteria and they are 100% tested before leaving the facility.The vendor also reports that in (b)(4) 2014 the formulation of the polypropylene material used for the blue measurement indicator on the packet peaks was changed.The change does not affect the fit, form, function, appearance, or safety of the pocket peaks.The material change was made to improve the consistency of the blue measurement indicator.If the sample is returned, a follow-up report will be submitted with investigation results.

• Brand Name: HUDSON POCKET PEAK FLOW METER
• Type of Device: PEAK FLOW METER
• Manufacturer (Section D): TELEFLEX; research triangle park NC
• Manufacturer Contact: katharine tarpley ; po box 12600; research triangle park, NC 27709 ; 9194334854
• MDR Report Key: 4062911
• MDR Text Key: 20105278
• Report Number: 1044475-2014-00256
• Device Sequence Number: 1
• Product Code: BZH
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1