MAUDE Adverse Event Report: COOK INC TURBO-JECT® SINGLE LUMEN MINOCYCLINE/RIFAMPIN POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this report indicate the information is unknown or unavailable.(b)(6).(b)(4).Event is still under investigation at this time.
Event or Problem Description
The (b)(6) male patient is a military vet with ptsd and lyme disease.During a procedure, while trying to get wire access, the user was pulling the wire back and forth when the tip sheared off in the patient.The tip is lodged in the patients tissue of his arm.It is to be determined if and when the piece will be removed.If removed the physician is planning to do a cut down procedure to remove the tip fragment.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned, therefore no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use.Each wire guide is provided with an attached caution label which states: "withdrawal and/or manipulation of the distal spring coil portion of the wire guide through the needle tip may result in breakage.¿ based on the information provided and results of the investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Monitoring for similar complaints will continue.
Event or Problem Description
It was reported that while trying to obtain wire access, the user pulled the wire back and forth and the tip of the turbo-ject single lumen minocycline/rifampin power-injectable picc sheared off in the patient and became lodged in the tissue of his arm.No information was provided regarding the patient outcome or any additional intervention or procedures; however, a cut down procedure to remove the tip would be performed if deemed necessary by the physician.

• Brand Name: TURBO-JECT® SINGLE LUMEN MINOCYCLINE/RIFAMPIN 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: 6167197
• Report Number: 1820334-2016-01538
• Device Sequence Number: 376573
• Product Code: LJS
• UDI-Device Identifier: 00827002239081
• UDI-Public: (01)00827002239081(17)170819(10)6292655
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-5.0-CT-NT-ABRM-1111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 07/20/2017
• 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
• Patient Age: 30 YR