MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
A picc line was placed in the arm of the male patient on (b)(6) 2016.Due to agitation, the patient picked at his am and the picc line; which resulted in the line completely separating from the hub.The line was replaced.It is believed the patient is the source of the malfunction but the line should not have disconnected.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation : a review of the complaint history, device history record and specifications was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
A picc line was placed in the arm of the male patient on (b)(6) 2016.Due to agitation, the patient picked at his am and the picc line; which resulted in the line completely separating from the hub.The line was replaced.It is believed the patient is the source of the malfunction but the line should not have disconnected.The patient did not experience any adverse effects due to this occurrence.

• Brand Name: TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5752670
• Report Number: 1820334-2016-00542
• Device Sequence Number: 18025
• Product Code: LJS
• UDI-Device Identifier: 00827002239012
• UDI-Public: (01)00827002239012(17)180426(10)6916109
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-5.0-CT-1111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/25/2016
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1