MAUDE Adverse Event Report: COOK INC COOK TPN DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).This event is currently under investigation.A follow-up report will generated upon the completion of the investigation.
Event or Problem Description
Information was provided that the transplant patient has had ongoing issues with blood back flowing into the cap of the blue lumen; which led to the line occluding and requiring replacement.The above information is for the new line inserted on (b)(6); which also had back flowing blood into the icu medical microcalve cap.Interventions to mitigate the blood in the cap include taping / reinforcing the clamp on the line and adding an icu medical neutron (anti-reflux) cap.The patient has not been harmed but has had to have 2 procedures to rewire new central lines and received alteplase many times due to issues with occlusion in the line; these all have risk associated with them.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu) and specifications was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was 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, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK TPN DOUBLE LUMEN TPN CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6278769
• Report Number: 1820334-2017-00037
• Device Sequence Number: 16455761
• Product Code: FOZ
• UDI-Device Identifier: 00827002120228
• UDI-Public: (01)00827002120228(17)170301(10)4846837
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2017

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: C-TPNS-6.0D-65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 06/15/2017
• 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