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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 Problems Unraveled Material (1664); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2024
Event Type  malfunction  
Event Description
It was reported that the wire included in the cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set unraveled upon removal during an unknown procedure on a 55-year-old male patient.The physician experienced difficulty when advancing the wire into the blood vessel through the needle.The wire was then withdrawn and was found to be "deformed." a new like-device was opened to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.The customer provided a photo to the manufacturer that showed the wire to be unraveled.The wire was withdrawn or manipulated through the needle.
 
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D1 - device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set e1 - customer (entity): (b)(6) hospital, ; phone: (b)(6) ; postal code: (b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
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Type of Device
FOZ 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 Key19144988
MDR Text Key341134888
Report Number1820334-2024-00553
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00827002478299
UDI-Public(01)00827002478299(17)260103(10)15469165
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,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberC-UTLM-701J-RSC-ABRM-HC-RD
Device Lot Number15469165
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/31/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age55 YR
Patient SexMale
Patient Weight76 KG
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