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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
The customer had informed the sales representative that every 6th catheter had broken.Update information provided on (b)(6) 2016 stated a new one (product) was inserted.Additional information has been requested but not provided by the reporter.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the device history record, specifications and examination of customer supplied photograph of the device was conducted during the investigation.A review of the customer-supplied photo(s) reveals a leak in the catheter tubing adjacent to the manifold.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.There is one other report for this lot number from the same reporting facility.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: REDO SINGLE LUMEN TPN CATHETER
• 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: 6083036
• Report Number: 1820334-2016-01360
• Device Sequence Number: 18974919
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)190106(10)6434836
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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): 07/17/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: C-TPN-6.5-90-REDO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 07/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention