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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
C.Suspect products: #3 ¿ chloraprep-3ml-orange-ster-sol-appl d1 - device 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: coordinator, inventory control.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 that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray contained an incorrect size catheter.A 7.0fr/15cm central venous catheter was found in packaging labeled 7.0fr/20cm.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Event or Problem Description
In additional information received on 20oct2025, the intensive care unit (icu) clinical staff reported that they were able to complete the procedure by opening a new like-device.
Additional Manufacturer Narrative
Additional information: b5.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h6 - annex a and annex g.Investigation ¿ evaluation.It was reported that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray contained an incorrect size catheter.A 7.0fr/15cm central venous catheter was found in packaging labeled 7.0fr/20cm.In additional information received on 20oct2025, the intensive care unit (icu) clinical staff reported that they were able to complete the procedure by opening a new like-device.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.Reviews of the documentation including the complaint history, device history record and quality control procedures of the device, were completed during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, a photo of the complaint device was provided by the customer for review.The photo confirmed that the catheter was 15cm instead of 20cm.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found that there were quality control discrepancies and sets were reworked.It should be noted that there were two other complaints associated with the final product lot number.Evidence provided upon review of the dmr, dhr, and device failure analysis, does indicate the device was manufactured out of specification.Based on the information provided, no returned product, and the results of this investigation, it was concluded that a manufacturing and quality control deficiency contributed to the reported event.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.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, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• 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: 23282032
• Report Number: 1820334-2025-01254
• Device Sequence Number: 12142347
• Product Code: FOZ
• UDI-Device Identifier: 00827002441286
• UDI-Public: (01)00827002441286(17)271031(10)16558073
• Combination Product (Y/N): Y
• Initial Reporter State: HI
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 02/27/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 10/23/2025; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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