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	12/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported a peripherally inserted central catheter (picc) in place for approximately 3 months was leaking between the hub and the catheter line outside of the patient¿s anatomy.A new picc line was inserted.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.No additional information was available at the time of this report.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, trends, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of a photograph of the returned device confirmed the presence of a split at the molded junction of the proximal hub of the device.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.

• 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: 6223498
• Report Number: 1820334-2017-00007
• Device Sequence Number: 10864804
• Product Code: LJS
• UDI-Device Identifier: 00827002561991
• UDI-Public: (01)00827002561991(17)180705(10)7094697
• Combination Product (Y/N): N
• PMA/510(K) Number: K111244
• 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): 04/14/2017

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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 04/14/2017
• 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