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

Catalog Number C-PICS-301J

Device Problem Split (2537)

Patient Problem Surgical procedure, additional (2564)

Event Date 11/24/2014

Event Type  Injury  

Event Description

The picc line inserted under ga in left cubical fossa.Seven days later, the picc was blocked and the anaesthetic registrar attempted to flush, however a "pop" sound was heard and fluid observed leaking from split in line between hub and securing flange (in clamping region).The picc line initially difficult to remove.The picc tip had 3cm occlusive clot noted a tip of catheter.The tip was intact.The patient required reinsertion of picc line.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• Brand Name: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: lary pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4417032
• MDR Text Key: 5164520
• Report Number: 1820334-2015-00016
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014,12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2017
• Device Catalogue Number: C-PICS-301J
• Device Lot Number: 5114730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/24/2014
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2014
• 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