MAUDE Adverse Event Report: COOK INC TURBO-JECT POWER INJECTABLE; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a patient had a peripherally inserted central catheter (picc) line implanted on (b)(6) 2016.The patient presented to the emergency department on (b)(6) 2016 with a leaking picc line.The patient was admitted to the hospital and a surgical procedure performed to remove and replace the leaking picc line.A section of the device did not remain inside the patient¿s body.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, device history record, specifications, quality control, trends and visual inspection of the returned device was conducted during the investigation.The device was returned for evaluation.Visual inspection noted the tubing was partially separated at the purple hub.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.There were no other reported complaints for this lot number.Based on the information provided and results of the investigation a definitive root cause could not be determined.Measures have been previously initiated to address this failure mode.Monitoring for similar complaints will continue.

• Brand Name: TURBO-JECT POWER INJECTABLE
• 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: 6192666
• Report Number: 1820334-2016-01540
• Device Sequence Number: 407270
• Product Code: LJS
• UDI-Device Identifier: 00827002561991
• UDI-Public: (01)00827002561991(17)180110(10)6508555
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Pharmacist
• 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-4.0-CT-OTW-ST-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 07/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention