MAUDE Adverse Event Report: COOK INC COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.D2a - additional common name: dre dilator, vessel, for percutaneous catheterization d2b - additional product code: dre.E3 - occupation: clinical value analysis specialist.G4 - pma/510(k) #: k182252.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.
Event or Problem Description
It was reported the catheter of a cook cvc single lumen central venous catheter set leaked.The customer observed the fluid dripping from the device without removing the cap from the lumen and without any intervention.It was also noted the device did not need to be "primed" due to this.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Event or Problem Description
This event no longer meets the qualifications for a reportable event.See h10.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.Additional information was provided on (b)(6) 2024.The customer clarified that reported device was not defective.There is no alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the device.Additionally, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.The complaint will be close/cancelled by the manufacturer.

• Brand Name: COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET
• Common Device Name: 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 Key: 18411925
• Report Number: 1820334-2023-01775
• Device Sequence Number: 8619310
• Product Code: FOZ
• UDI-Device Identifier: 00827002588318
• UDI-Public: (01)00827002588318(17)260124(10)15188398
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2026
• Device Model Number: N/A
• Device Catalogue Number: USLM-3.0-18J-1-5
• Device Lot Number: 15188398
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/09/2024
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown