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	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
It was reported after successfully inserting the picc, the user was in the process of peeling away the sheath but found it very difficult to split then as she was peeling it, the left yellow "handle" piece completely separated from the grey sheath.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, drawings, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.One used sheath was returned for examination.Examination of the returned device confirmed separation of the handle from the sheath.A document based investigation evaluation was also 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; specific items are addressed such as: "peel the sheath away from the catheter by grasping the two tabs of the sheath, snapping them down, and pulling outward and upward.Note: be sure to maintain stable catheter position while peeling sheath away." based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6117826
• Report Number: 1820334-2016-01339
• Device Sequence Number: 52310
• Product Code: LJS
• UDI-Device Identifier: 00827002345218
• UDI-Public: (01)00827002345218(17)180811(10)7187070
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: UPICS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 04/12/2017
• Patient Sequence Number: 1