WAYNE PNEUMOTHORAX TRAY N/A C-UTPTY-1400-WAYNE-112497-IMH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-02 for WAYNE PNEUMOTHORAX TRAY N/A C-UTPTY-1400-WAYNE-112497-IMH manufactured by Cook Inc.

Event Text Entries

[178149155] Occupation: coordinator. Pma/510(k) #: exempt. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10


[178149156] It was reported that the "end-piece" of the wire in a wayne pneumothorax set appeared "cut, but still a little attached". This likely means that the wire was unraveled, as it was also reported "the wire is not fully attached". A new wire was opened and used to completed the intended procedure successfully. No patient contact was made and no adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2020-00021
MDR Report Key9538270
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-02
Date of Report2020-02-27
Date Mfgr Received2020-02-07
Device Manufacturer Date2019-09-27
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. JENNIFER CANADA
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8123392235
Manufacturer G1COOK INC
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal Code47404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameWAYNE PNEUMOTHORAX TRAY
Generic NameJOL CATHETER AND TIP, SUCTION
Product CodeJOL
Date Received2020-01-02
Returned To Mfg2020-01-02
Model NumberN/A
Catalog NumberC-UTPTY-1400-WAYNE-112497-IMH
Lot Number10005738
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-02

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