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

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 05/29/2015

Event Type  Injury  

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 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
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6895164
• MDR Text Key: 87447135
• Report Number: 1820334-2017-03308
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002085206
• UDI-Public: (01)00827002085206(17)180117(10)5584107
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: PICDS-701-MPIS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR