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

Model Number	G56194
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(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 during insertion of the picc line, the wire guide became stuck in the catheter and force had to be used by the doctor in order to extract the wire guide from the patient.The rest of the procedure proceeded without incident and the picc line was successfully implanted in the patient.There were no injuries and no additional procedures.

• Brand Name: TURBO-JECT POWER INJECTABLE
• 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: 6869041
• Report Number: 1820334-2017-03061
• Device Sequence Number: 11114083
• Product Code: LJS
• UDI-Device Identifier: 00827002561946
• UDI-Public: (01)00827002561946(17)170903(10)6177784
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G56194
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1110
• 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: 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1