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

Catalog Number	PICDS-701-MPIS
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/29/2015
Type of Reportable Event	Serious Injury
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 the nurses discovered a pin prick hole in the catheter near the clamp on the yellow lumen side.It was inserted the day before and they noticed a leak during treatment then it became blocked.As a result, the device was removed and replaced the next day.

• Brand Name: DOUBLE 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: 6895164
• Report Number: 1820334-2017-03308
• Device Sequence Number: 13618025
• Product Code: FOZ
• UDI-Device Identifier: 00827002085206
• UDI-Public: (01)00827002085206(17)180117(10)5584107
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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 Catalogue Number: PICDS-701-MPIS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR