• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED SPECTRUM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK INCORPORATED SPECTRUM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number C-UTLMY-701J-RSC-ABRM-HC-IHI-F
Device Problems Difficult to Remove (1528); Material Deformation (2976)
Patient Problem Insufficient Information (4580)
Event Date 05/14/2021
Event Type  malfunction  
Event Description
Dr. Was placing central line on patient. It was stated that the guidewire was hanging up and had difficulties removing. It appeared to kink the catheter. It was stated that this type of kit is not preferred. Cook spectrum central venous tray, ref# c-utlmy-701j-rsc-abrm-hc-ihi-f, ref g49804, lot 13376036. Central line was removed, discarded and replaced. I saved the cover/lid to the kit, but not the catheter or guidewire.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPECTRUM
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key11893326
MDR Text Key252966054
Report Number11893326
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-UTLMY-701J-RSC-ABRM-HC-IHI-F
Device Lot Number13376036
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/18/2021
Event Location Hospital
Date Report to Manufacturer05/27/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-