MAUDE Adverse Event Report: COOK INC TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported a "picc line was placed on (b)(6) 2016 and on (b)(6) 2016 it was noted that the hub was completely detached from the catheter.At the time of this report the physician has not stated how they will proceed.Currently the customer does not have a picc line in place." no additional information was available at the time of this report.
Additional Manufacturer Narrative
A review of the complaint history, device history record, quality control, and trends was conducted during the investigation.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record was conducted.The lot met all finished goods release criteria.The device is shipped with an instruction for use (ifu) that states: "the maximum pressure limit setting for power injectors used with the turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the flow rate indicated".Based on the information provided the root cause could not be determined.Measures have been previously initiated to address this issue.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported a "picc line was placed on (b)(6) 2016 and on (b)(6) 2016 it was noted that the hub was completely detached from the catheter.At the time of this report the physician has not stated how they will proceed.Currently the customer does not have a picc line in place." no additional information was available at the time of this report.Additional information received on 12/09/2016: the patients' picc line was not replaced.

• Brand Name: TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• 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: 6178328
• Report Number: 1820334-2016-01450
• Device Sequence Number: 413758
• Product Code: LJS
• UDI-Device Identifier: 00827002558854
• UDI-Public: (01)00827002558854(17)171117(10)6322981
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-80NT-1110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention