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

Catalog Number PICS-501-MPIS-NT

Device Problem Crack (1135)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 01/30/2014

Event Type  Injury  

Event Description

A (b)(6) male pt underwent a procedure with use of a single lumen peripherally inserted central venous catheter set.The lumen-lock connector broke.The luer-lock of picc cracked during the injection in the haematological unit.The picc had been implanted in radiology.Additional info received (b)(4) 2014: it was necessary to replace the broken picc with a new picc.The pt was already in the department and was recalled to the interventional room for replacement.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: SINGLE 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.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3672116
• MDR Text Key: 15267615
• Report Number: 1820334-2014-00080
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/30/2014

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: 04/30/2016
• Device Catalogue Number: PICS-501-MPIS-NT
• Device Lot Number: 4240342
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2014
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2014
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2013
• 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: 64 YR