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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC

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COOK INC Back to Search Results
Model Number N/A
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: event occurred sometime in summer 2019. Suspect medical device: product information currently unavailable. The complaint devices were reported to be double and single lumen picc lines. Common device name: either foz or ljs. (b)(6). Pma/510(k) #: 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 double and single lumen picc lines are getting blocked. The nurses using the devices reported the picc lines get blocked, and rinsing them does not remove the blockage. Positive pressure valves were used to prevent blood reflux, but they were not the valves provided in the cook set. Additional information regarding event and device details has been requested, but is currently unavailable. No other adverse effects have been reported for this incident.
 
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Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key9280447
MDR Text Key176799802
Report Number1820334-2019-02786
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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