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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 N/A
Device Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2021
Event Type  malfunction  
Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter. Initial reporter customer (person), phone number: (b)(6). 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 discovered upon device return that the wire guide of a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter had separated. It was initially reported that the wire guide was difficult to remove from the device as it was withdrawn following catheter placement in the subclavian vein. The physician removed both the wire and catheter together and opened a new device for an attempted second placement. The same issue with difficult wire removal occurred with the new device. A third device was opened to successfully complete the procedure. It was later reported that imaging guidance was used to place the catheter, and no resistance was felt when advancing the wire guide. During placement, the distal tip of the wire was always leading the distal tip of the catheter. Upon return of the two complaint devices to the manufacturer, it was discovered that one wire guide was separated. Two occluded catheters were also found and are referenced in the report with patient identifier: (b)(6).
 
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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
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key11852397
MDR Text Key266891482
Report Number1820334-2021-01365
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00827002508170
UDI-Public(01)00827002508170(17)220608(10)13069664
Combination Product (y/n)Y
PMA/PMN Number
K081113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2022
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 Expiration Date06/08/2022
Device Model NumberN/A
Device Catalogue NumberC-UDLM-801J-ABRM-HC
Device Lot Number13069664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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