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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION
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COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION Back to Search Results
Catalog Number C-PPD-600-WCE-IMH
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/26/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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
It was reported that the fuhrman pleural/pneumopericardial drainage set split upon opening the package.The device was not used on a patient, and there were no injuries or additional procedures.
 
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Brand Name
FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
Type of Device
GBX CATHETER, IRRIGATION
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7374946
MDR Text Key103919298
Report Number1820334-2018-00876
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00827002557147
UDI-Public(01)00827002557147(17)171211(10)5510612
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberC-PPD-600-WCE-IMH
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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