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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 G44128
Device Problems Partial Blockage (1065); Fluid Leak (1250)
Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2021
Event Type  Injury  
Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray. Catalog number/rpn: c-utlmy-701j-rsc-abrm-hc-fst-a-rd. Initial reporter customer (person): line 2: (b)(6). (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was found to be leaking at the insertion site. The catheter was initially implanted on (b)(6) 2020 and began leaking on (b)(6) 2021. After the leak was noted, the device was replaced with no issues. No other adverse effects have been reported. Additional information has been requested regarding patient/event details but is not currently available.
 
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Brand NameCOOK SPECTRUM
Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key11336925
MDR Text Key232196437
Report Number1820334-2021-00343
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
PMA/PMN Number
K081113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2021
Device Model NumberG44128
Device Catalogue NumberC-UTLMY-701J-RSC-ABRM-HC-FST-A-RD
Device Lot Number13411570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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