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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX TRAY DQR CANNULA, CATHETER

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COOK INC WAYNE PNEUMOTHORAX TRAY DQR CANNULA, CATHETER Back to Search Results
Catalog Number C-UTPTY-1400-WAYNE-112497
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
The complainant reported reversal of the intended orientation of the heimlich valve from the wayne pneumothorax tray. This product problem did not result in any reported serious injuries to the patient.
 
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Brand NameWAYNE PNEUMOTHORAX TRAY
Type of DeviceDQR CANNULA, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key8175789
MDR Text Key131004226
Report Number1820334-2018-03814
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-UTPTY-1400-WAYNE-112497
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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