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	12/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
A picc was placed in the patient on the (b)(6) of (b)(6) 2016.It was used every day without any issue.On the (b)(6) of (b)(6) 2016, a leak of physiological serum with blood occurred at the proximal end of the picc.The patient had the shivers.The doctor advised that the picc line had a cut at the junction between the extender and the luer lock female connection.A peripheric venous transfusion was done immediately.On the (b)(6) of (b)(6) 2016, they took the faulty picc out of the patient and replaced it with a new one.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 complaint history, device history record, quality control, trends, and visual inspection of the returned device was conducted during the investigation.One turbo-ject power injectable catheter was returned for evaluation.Visual examination noted that the clear tubing was partially severed from the purple hub.A document based investigation evaluation was also performed.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 initiated to address this issue.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: 6202472
• Report Number: 1820334-2016-01632
• Device Sequence Number: 763255
• Product Code: LJS
• UDI-Device Identifier: 00827002561991
• UDI-Public: (01)00827002561991(17)180608(10)7027770
• 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: Physician
• 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: 12/14/2016
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 07/20/2017
• 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