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

Model Number	G44128
Medical Device Problem Codes	Nonstandard Device (1420); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray contained a 15 cm length catheter instead of a 20 cm length catheter as stated on the packaging label.The issue was noted upon the packaging, and the device was not used.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.C1 - suspect products: #3 ¿ rifampicin/minocycline hcl 1000g/kg d1 - brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray d4 - catalog #: c-utlmy-701j-rsc-abrm-hc-fst-a-rd e3 - occupation: value analysis team specialist 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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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 47401
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47401 ; 8123392235
• MDR Report Key: 24305441
• Report Number: 1820334-2026-00155
• Device Sequence Number: 5314747
• Product Code: FOZ
• UDI-Device Identifier: 00827002441286
• UDI-Public: (01)00827002441286(17)271031(10)16558073
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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 Model Number: G44128
• Device Lot Number: 16558073
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 04/15/2025
• 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