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

Catalog Number	UPICDS-5.0-CT-OTW-ST-ABRM-1111
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a wire guide "became stuck" while attempting to remove the wire guide from the distal lumen of a turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc line.A different wire was placed through the second lumen and a new picc line was run over the wire.At an unknown point during the procedure, the first wire was successfully removed.The procedure was completed and the reported device issue caused "just a little pain" at the insertion site (arm).As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK SPECTRUM TURBO-JECT
• 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: 7748030
• Report Number: 1820334-2018-02227
• Device Sequence Number: 1280731
• Product Code: LJS
• UDI-Device Identifier: 00827002239166
• UDI-Public: (01)00827002239166(17)190628(10)8561939
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2019
• Device Catalogue Number: UPICDS-5.0-CT-OTW-ST-ABRM-1111
• Device Lot Number: 8561939
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1