MAUDE Adverse Event Report: COOK INC TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2017
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
International customer reported that a patient was scheduled for a turbo-ject double lumen peripherally inserted central venous catheter placement.The clinical staff observed that the peel away sheath of the device set was broken when the packet was opened.The event was noted prior to use and patient contact.A replacement set was obtained and the procedure completed uneventfully.There are no reported adverse patient consequences.The device is reportedly available for evaluation; the device was not received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
A review of the device history record, documentation, drawing, instructions for use, 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 instructions for use that describes its intended use, specifically: "how supplied - upon removal from package, inspect the product to ensure no damage has occurred".Based on the information provided, no product returned 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 DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• 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: 6490196
• Report Number: 1820334-2017-00655
• Device Sequence Number: 18855911
• Product Code: LJS
• UDI-Device Identifier: 00827002491670
• UDI-Public: (01)00827002491670(17)190124(10)7620163
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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-OTW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1