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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A visual examination noted the tubing is partially severed from the white hub.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that, 77 days following implantation, the turbo-ject® double lumen power-injectable picc (peripherally inserted central catheter) line began leaking from the white hub area of the device.The product problem ultimately necessitated the exchanging of the line.No further complications or were reported.The customer also reported device was being flushed with saline and then 1 ml heparin locked (10 units/ml) twice a day.In addition, 1 ml of 70 percent ethanol was placed to dwell for four hours every saturday, a total of 12 ethanol locks since (b)(6) 2017 had been performed.The picc line was being utilized for intermittent medications: bumetanide, ativan (lorazapam), chlorathiazide and potassium chloride.The device has been returned for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
A review of the complaint history, device history record, drawings, documentation, manufacturing instructions, specifications, and quality control data was conducted during the investigation.One device was returned for the investigation.A visual examination noted the tubing is partially severed from the white hub.A review of the device history record found no other non-conformances associated with the complaint device lot number (7970093).Additionally, review of the manufacturer's complaint database found no other complaint associated with the complaint device lot number (7970093).Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information, inspection of returned product and the results of our investigation, a definitive root cause could not be determined.This failure mode has been escalated per internal processes.

• Brand Name: TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC
• 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: 7177059
• Report Number: 1820334-2018-00009
• Device Sequence Number: 16495772
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)190607(10)7970093
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 03/29/2018
• 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