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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION
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COOK INC PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION Back to Search Results
Catalog Number C-PCS-PHH
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/05/2015
Type of Reportable Event Malfunction
Additional 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.Blank fields on this form indicate the information is unknown or unavailable.
 
Event or Problem Description
It was reported that after insertion of the catheter from the pericardiocentesis catheter set, it was discovered that fluid was leaking from the hub area.The leaking catheter was then removed and a new one inserted.There were no injuries or additional procedures reported.
 
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Brand Name
PERICARDIOCENTESIS CATHETER SET
Common Device Name
GBX CATHETER, IRRIGATION
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7375186
Report Number1820334-2018-00880
Device Sequence Number16406925
Product Code GBX
UDI-Device Identifier00827002435582
UDI-Public(01)00827002435582(17)171125(10)5473716
Combination Product (Y/N)N
Initial Reporter CountrySG
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberC-PCS-PHH
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/23/2018
Initial Report FDA Received Date03/27/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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