MAUDE Adverse Event Report: COOK INC NEFF PERCUTANEOUS ACCESS SET; KGZ, ACCESSORIES, CATHETER

Model Number	G10544
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: pma/510(k) #: exempt.H3: device evaluated by mfg? device evaluation anticipated but has not begun.Awaiting device return.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 discovered by a distribution facility that the packaging of one neff percutaneous access set was unsealed.The product did not reach a point of use.No patient contact was made with the device.No adverse effects have been reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.It was discovered by a distribution facility that the packaging of one neff percutaneous access set was unsealed.The product did not reach a point of use.No patient contact was made with the device.No adverse effects have been reported.Reviews of the documentation, including the complaint history, device history record (dhr), manufacturing instructions and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One unused set returned, in which a missing seal was confirmed upon a visual examination.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the dhr for the reported complaint device lot revealed no relevant nonconformances relevant to the failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review the device labeling, as an ifu pamphlet is not included with the complaint device.Evidence gathered upon review of the returned product indicates the device was manufactured out of specification.However, the review of the dmr and dhr suggests that there are no additional nonconforming products in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a manufacturing 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.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Common Device Name: KGZ, ACCESSORIES, CATHETER
• 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: 21691782
• Report Number: 1820334-2025-00288
• Device Sequence Number: 18325631
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)271108(10)16333764
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 Model Number: G10544
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 16333764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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