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	11/19/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name- spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc.(b)(4).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
The customer reported that 65 days after implantation, the picc line began leaking due to a split in the clear plastic just below the hub.The picc was replaced with another device.No part of the original device remained in the patient, and there were no further injuries aside from the additional procedure.

• 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: 6869000
• Report Number: 1820334-2017-03060
• Device Sequence Number: 10939113
• Product Code: LJS
• UDI-Device Identifier: 00827002345454
• UDI-Public: (01)00827002345454(17)160301(10)4966255
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2017

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2017
• 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