MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G03267
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/17/2015
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
During retrieval, the clamp which functions to release the device was not working, so another clamp was required to remove the peel away sheath as its tabs were being released.The physician used another product to finish the procedure.No adverse effects to the patient were reported as a result of this incident.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6896953
• Report Number: 1820334-2017-03152
• Device Sequence Number: 18997521
• Product Code: FOZ
• UDI-Device Identifier: 00827002032675
• UDI-Public: (01)00827002032675(17)170501(10)4986837
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G03267
• Device Catalogue Number: C-PICS-501J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/27/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention