MAUDE Adverse Event Report: COOK INC; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: spectrum turbo-ject double lumen minocycline/rifampin bedside power-injectable picc.Device pro-code: ljs turbo-ject peripherally inserted central venous catheter.(b)(4).The event is currently under investigation.
Event or Problem Description
A picc procedure was performed on the (b)(6) male patient and it was reported that two months after placement, the white lumen was leaking.A new picc was placed and due to the patient's sluggish blood return and difficulty in flushing, the user administered tpa in the white port just after one week.No additional information was provided regarding patient outcome.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions and visual inspection of the returned device was conducted during the investigation.One used 4.0 fr catheter was returned for evaluation inspection of the returned device found the clear extension tubing is partially separated directly below the white luer locking hub.A small section of tubing remained inside the white luer locking hub.The tubing was not stretched or elongated.No other physical damage was noted.A document based investigation evaluation was also 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.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Measures have been initiated to address this failure mode.

• 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: 6100170
• Report Number: 1820334-2016-01345
• Device Sequence Number: 16215140
• Product Code: LJS
• UDI-Device Identifier: 00827002345454
• UDI-Public: (01)00827002345454(17)180323(10)7085821
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: UPICDS-4.0-CT-40NT-ABRM-1111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 04/12/2017
• 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
• Patient Age: 14 YR