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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC Cook Spectrum; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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COOK INC Cook Spectrum; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number G53599
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/02/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Cook spectrum minocycline/rifampin impregnated lumen central venous catheter set.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
It was reported that prior to patient contact, the tip of the guide wire was broken.Device imaging identified coil separation.
 
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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 Key6858726
Report Number1820334-2017-02672
Device Sequence Number117819
Product Code FOZ
UDI-Device Identifier00827002535992
UDI-Public(01)00827002535992(17)170801(10)5239259
Combination Product (Y/N)N
Initial Reporter CountryKR
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/12/2017
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 No Information
Device Model NumberG53599
Device Catalogue NumberC-UTLM-701J-ABRM-HC-RD-P
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 Date09/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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