HUDSON POCKET PEAK FLOW METER 1801

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-20 for HUDSON POCKET PEAK FLOW METER 1801 manufactured by Teleflex.

Event Text Entries

[17263513] 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.
Patient Sequence No: 1, Text Type: D, B5


[17497592] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1044475-2014-00254
MDR Report Key4062909
Report Source06,07
Date Received2014-08-20
Date of Report2014-08-08
Date of Event2014-08-04
Date Mfgr Received2014-08-08
Date Added to Maude2014-09-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKATHARINE TARPLEY
Manufacturer StreetPO BOX 12600
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone9194334854
Manufacturer Street2917 WECK DR.
Manufacturer CityRESEARCH TRIANGLE PARK NC 27709
Manufacturer CountryUS
Manufacturer Postal Code27709
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUDSON POCKET PEAK FLOW METER
Generic NamePEAK FLOW METER
Product CodeBZH
Date Received2014-08-20
Catalog Number1801
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX
Manufacturer AddressRESEARCH TRIANGLE PARK NC US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-08-20

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