MAUDE Adverse Event Report: COOK INC SPECTRUM ANTIBIOTIC-IMPREGNATED DOUBLE LUMEN CUFFED HYPERALIMENTATION CATHETER; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G51199
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The customer reported that there were small pinholes found in the tubing between the hub and the junction.This was noticed immediately after the tube was placed, so they replaced it with a new device.No part of the original device remained in the patient, and there were no injuries or additional procedures.

• Brand Name: SPECTRUM ANTIBIOTIC-IMPREGNATED DOUBLE LUMEN CUFFED HYPERALIMENTATION 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: 6880275
• Report Number: 1820334-2017-03146
• Device Sequence Number: 13612244
• Product Code: FOZ
• UDI-Device Identifier: 00827002511996
• UDI-Public: (01)00827002511996(17)160924(10)NS6048423
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G51199
• Device Catalogue Number: HASDC-7.0-RSC-ABRM
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1