MAUDE Adverse Event Report: COOK INC Cook Spectrum Turbo-Ject; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G34545
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name- spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc.(b)(4).The patient required an additional procedure to replace the device as a result of the product problem.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
A patient had the picc line 2 months prior.It was stated to the facility that when the medication was injected, it could be felt going in.The picc line was removed and replaced.Upon looking at the picc line, it had ruptured.The patient had ethanol lock each day for four hours over the previous 2 months.The use of the ethanol was discontinued because of the belief that the ethanol could have potentially been allowing clot occlusion.Subsequently, heparin lock was used.The catheter was placed in femoral location.The rupture site would correspond to a level in the iliac vein near bifurcation.The tip was cut off for culture purposes.Aside from the additional procedure to replace the device, there were no other reported adverse effects to the patient.

• Brand Name: Cook Spectrum Turbo-Ject
• 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: 6876014
• Report Number: 1820334-2017-03103
• Device Sequence Number: 13568395
• Product Code: LJS
• UDI-Device Identifier: 00827002345454
• UDI-Public: (01)00827002345454(17)160514(10)6153162
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: G34545
• Device Catalogue Number: UPICDS-4.0-CT-40NT-ABRM-1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/19/2017
• 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