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U.S. Department of Health and Human Services

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

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COOK INC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: reported as unsure but possibly a day or two before (b)(6) 2021. Device name: cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set. Rpn: c-uqlm-1001j-rsc-abrm-hc-rd-au. Initial reporter occupation: unknown. 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 red particulate matter was observed while flushing the lumen of a cook spectrum minocycline/rifampin impregnated five lumen central venous catheter set. The spectrum 5 lumen central venous catheter was being flushed prior to insertion when red particles were observed to be coming from the catheter. From a photo provided, these particles could also be seen adhering to the outside of the catheter. A new like device was opened and checked for particles. As there were no particulate matter present, the replacement device was used to complete the procedure successfully. It was noted that the replacement device was most likely from the same lot. The patient did not experience any adverse effects due to this occurrence.
 
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Type of DeviceFOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11852212
MDR Text Key266890119
Report Number1820334-2021-01363
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 foreign,health professional,o
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Lot Number13333179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No

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