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U.S. Department of Health and Human Services

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

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COOK INCORPORATED COOK SPECTRUM CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number G21053
Device Problem Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2021
Event Type  malfunction  
Event Description
Physician was inserting trans lumenal catheter using cook spectrum central venous catheter tray minocycline/rifampin antibiotic impregnated. Lot # 13628350 ref# g21053. While she was advancing the wire, she had it in approximately 6-8 inches when there was a 90 degree angle in the wire, she was unable to advance the catheter over the wire d/t the 90 degree angle. Anesthesia was called to insert a tlc in the left jugular.
 
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Brand NameCOOK SPECTRUM
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key12083680
MDR Text Key258962280
Report Number12083680
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
Type of Report Initial
Report Date 06/15/2021,05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG21053
Device Catalogue NumberC-UTLMY-701J-ABRM-CUSTOM-0018
Device Lot Number13628350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/15/2021
Event Location Hospital
Date Report to Manufacturer06/29/2021
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

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