MAUDE Adverse Event Report: COOK INC PERICARDIOCENTESIS CATHETER SET; GBX CATHETER, IRRIGATION

Catalog Number	C-PCS-PHH
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2015
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.
Event or Problem Description
It was reported that after insertion of the pericardiocentesis catheter, it was discovered that fluid was leaking from the hub area.The catheter was not removed, as the physician did not want to re-insert another catheter into the patient.The catheter continued to leak until it was taken out at discharge on (b)(6).There were no injuries or additional procedures reported.

• Brand Name: PERICARDIOCENTESIS CATHETER SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7377653
• Report Number: 1820334-2018-00881
• Device Sequence Number: 19118620
• Product Code: GBX
• UDI-Device Identifier: 00827002435582
• UDI-Public: (01)00827002435582(17)170822(10)5232773
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• Number of Events Summarized: 1
• 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): 03/28/2018

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 Number: C-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 Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70