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

Model Number	N/A
Medical Device Problem Codes	Kinked (1339); Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.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
The customer reported that, during a central line insertion procedure in which the spectrum minocycline/rifampin impregnated double lumen central venous catheter was employed, the wire got hung up on the needle.This reportedly caused the wire guide to kink and unravel.A smaller wire guide was ultimately used to complete the procedure, and the customer confirmed that the product malfunction did not necessitate any additional procedures or result in any patient adverse events.The device has reportedly been disposed of and is unavailable for return and evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of the drawing, instructions for use(ifu), device history record, quality control and manufacturing instructions were conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.A document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances associated with the complaint device lot number.It should be noted there were no other reported complaints for this lot number.The described event could have been caused by the wire or needle.It was not identified which needle in the set was utilized.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: COOK SPECTRUM
• 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: 7173923
• Report Number: 1820334-2018-00064
• Device Sequence Number: 1485795
• Product Code: LJS
• UDI-Device Identifier: 00827002508194
• UDI-Public: (01)00827002508194(17)200301(10)8245935
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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 Model Number: N/A
• Device Catalogue Number: C-UDLMY-801J-ABRM-HC-FST-A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1