WAYNE PNEUMOTHORAX TRAY C-UTPTY-1400-WAYNE-112497

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for WAYNE PNEUMOTHORAX TRAY C-UTPTY-1400-WAYNE-112497 manufactured by Cook Inc.

Event Text Entries

[131002569] This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10


[131002570] The complainant reported that a patient in the ed (emergency department) needed a chest tube for a pneumothorax, and there was substantial difficulty with the wayne pneumothorax tray. The kits (two lot numbers: this mfr# and related mfr# 1820334-2018-03815) had kinks and frays in the guide wire that made it impossible to thread the chest tube into the chest cavity for pneumothorax drainage. It took 6 attempts to insert a chest tube into the patient, and the patient was awaiting ir for placement of a small chest tube. The physicians all attempted various ways/ workarounds with the only success being placing a pediatric tube for temporary inflation of the patient's lung. After xr (x-ray) confirmation, it was determined that a larger chest tube was necessary. Hence a subsequent attempt and failure. These product problem did not result in any reported serious injuries to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1820334-2018-03816
MDR Report Key8176799
Date Received2018-12-18
Date of Report2018-12-18
Date of Event2015-08-15
Date Mfgr Received2018-12-14
Device Manufacturer Date2014-09-30
Date Added to Maude2018-12-18
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 ContactMR. LARRY POOL
Manufacturer Street750 DANIELS WAY
Manufacturer CityBLOOMINGTON IN 47404
Manufacturer CountryUS
Manufacturer Postal47404
Manufacturer Phone8128294891
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 Report0

Device Details

Brand NameWAYNE PNEUMOTHORAX TRAY
Generic NameDQR CANNULA, CATHETER
Product CodeDQR
Date Received2018-12-18
Model NumberNA
Catalog NumberC-UTPTY-1400-WAYNE-112497
Lot Number5290799
Device Expiration Date2016-08-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK INC
Manufacturer Address750 DANIELS WAY BLOOMINGTON IN 47404 US 47404


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.