MAUDE Adverse Event Report: COOK, INC. TURBO-JET STANDARD POWER INJECTABLE PICC LINE PICC; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30DAYS

Catalog Number UPICS-5.0-CT-NT-1110

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Skin Irritation (2076)

Event Date 04/14/2014

Event Type  Injury  

Event Description

The patient has irritated skin from using the statlock to secure the picc line.Statlock is not a cook product but delivered with the package to initial placement of the picc line.No additional info has been provided by the reporter.

Manufacturer Narrative

(b)(4).Per info supplied by the customer, no product will be returned.A review of complaint history, the device's instructions for use (ifu), and quality control were conducted.Quality control checks that surface is clean and free of any surface imperfections.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an ifu which states warnings, precautions and instructions for use.We are inconclusive as to why this failure mode occurred.Quality engineering risk assessment was used to access the risk of this complaint.The addition of this complaint does not change the conclusion that no further risk reduction is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

• Brand Name: TURBO-JET STANDARD POWER INJECTABLE PICC LINE PICC
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita hardem, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3800220
• MDR Text Key: 4526642
• Report Number: 1820334-2014-00198
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K010034
• 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: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UPICS-5.0-CT-NT-1110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/14/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other