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

Model Number	G23905
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a leak was found on a turbo-ject® double lumen over-the-wire power-injectable picc at the proximal tip after connection to the pump.A new picc line was necessary; therefore, implantation of the new line was completed which resulted in an extension of their hospital stay.
Additional Manufacturer Narrative
Additional information: investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One device was returned for investigation.A visual examination of the returned catheter noted the catheter had partially separated from the purple hub.Quality control specification confirm correct extension tube with winged flla and that they are securely attached.Inspection method: level i, measure tube outside diameter with calipers or micrometer.Visually examine.Manually tug.The complaint is confirmed.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event for continuing consideration.
Event or Problem Description
It was reported a nurse noticed there was a leak of the turbo-ject® double lumen over-the-wire power-injectable picc located right below the luer-lock part of one of the two lumens.The peripherally inserted central catheter (picc) was removed and replaced.No other adverse consequences to the patient were reported.

• Brand Name: TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE 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: 7489797
• Report Number: 1820334-2018-01328
• Device Sequence Number: 18859247
• Product Code: LJS
• UDI-Device Identifier: 00827002239050
• UDI-Public: (01)00827002239050(17)191121(10)8389811
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: G23905
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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
• Patient Age: 60 YR