MAUDE Adverse Event Report: COOK INC Cook Spectrum; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G36206
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name- spectrum antibiotic-impregnated single lumen peripherally inserted central venous catheter set.(b)(4).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 12 hours after placement, the device began to leak at the connector, necessitating replacement of the device.There were no further injuries aside from the replacement procedure.

• Brand Name: Cook Spectrum
• 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: 6880785
• Report Number: 1820334-2017-03145
• Device Sequence Number: 11064936
• Product Code: FOZ
• UDI-Device Identifier: 00827002362062
• UDI-Public: (01)00827002362062(17)160901(10)5201271
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: G36206
• Device Catalogue Number: C-PICS-401J-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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 64