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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Sedation (2368); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
After placement of a picc line on a (b)(6) year old male patient, the line ruptured between the extension and the final connection.The patient required sedation and a new picc line implanted.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the device history record, documentation and specifications 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.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: TURBO-JECT SINGLE 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: 5761106
• Report Number: 1820334-2016-00532
• Device Sequence Number: 1695
• Product Code: LJS
• UDI-Device Identifier: 00827002558830
• UDI-Public: (01)00827002558830(17)170918(10)6216082
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2016

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-NT-1110
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 10/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1