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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Phone number was not provided.(b)(4).This event is currently under investigation.
Event or Problem Description
Vascular access insertion nurse has reported that the picc catheter was leaking at the junction between the purple hub and the clear flexible tubing.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: during the course of investigation, a review of the complaint history, device history record, specifications and a visual inspection of the returned was performed.Per specification, the integrity of this device is verified throughout the manufacturing process.A review of the work order and device history record determined that no non-conformances were noted and this is the only reported complaint associated with the provided lot number.A visual examination found there is a hole in the clear tubing adjacent to the purple hub.Based on the available information and the results of our investigation, a definitive root cause cannot be determined with certainty.We will continue to monitor this device and notify the appropriate internal personnel.
Event or Problem Description
Vascular access insertion nurse has reported that the picc catheter was leaking at the junction between the purple hub and the clear flexible tubing.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: TURBO-JECT® SINGLE 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: 5723439
• Report Number: 1820334-2016-00559
• Device Sequence Number: 647210
• Product Code: LJS
• UDI-Device Identifier: 00827002345218
• UDI-Public: (01)00827002345218(17)171214(10)6452975
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2016

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: UPICS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2016
• Supplement Report FDA Received Date: 09/19/2016
• 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: Other
• Patient Age: 63 YR