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

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
Customer reported that a patient received a turbo-ject® double lumen bedside power-injectable picc on an unspecified date.The device reportedly split at the junction where the catheter meets the hub.Event occurred "a few weeks" after initial implantation.The handling conditions and circumstances surrounding the event are not known.The actions by the clinical staff to address the event were not provided.Additional event and patient information was requested.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history records, instructions for use (ifu), specifications, and visual inspection was conducted during the investigation.Visual inspection and functional testing of the returned device were performed.The catheter portion returned measured 4.6 cm in length.A visual examination noted the clear tubing had partially separated at the purple hub.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 would contribute to this failure mode.There were no other reported complaints for this lot number.The turbo-ject® double lumen bedside power-injectable picc is shipped with instructions for use (ifu) which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically; ¿extreme caution must be used in placement and monitoring.Silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.If lumen flow is impeded, do not force injection or withdrawal of fluids.Catheter size should be as small as the use will allow.¿ based on the provided information, inspection of returned product, and results of the investigation, a definitive root cause cannot be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: TURBO-JECT® DOUBLE LUMEN BEDSIDE 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: 6727999
• Report Number: 1820334-2017-01900
• Device Sequence Number: 822037
• Product Code: LJS
• UDI-Device Identifier: 00827002239036
• UDI-Public: (01)00827002239036(17)181219(10)7532894
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2017

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: N/A
• Device Catalogue Number: UPICDS-5.0-CT-40NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/20/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1