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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3- occupation: inventory control coordinator sr.G4 ¿ pma/510(k) #: exempt.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 foreign particle was found in the sterile packaging of neff percutaneous access set.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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 unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that a foreign particle was found in the sterile packaging of a neff percutaneous access set.The device was not used, and no adverse effects have been reported.Reviews of the complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection of the returned sealed device, were conducted during the investigation.One unopened sealed device was received.Upon visual examination, particles were observed inside the unopened sealed package.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient controls are in place to detect this failure mode prior to release.The dhr for this complaint was reviewed.This final lot did not have any nonconformances.There are no related complaints on this lot.Additional related lots were reviewed and there were no complaints on these lots.Three of the related lots showed relevant nonconformances.However, all the nonconforming products were reworked, and all products in the lot were 100% inspected per quality control.The information provided upon review of the returned device indicates the device was manufactured out of specification.However, review of the dmr and dhr suggests that there are no additional nonconforming devices in house or in the field.This product is not supplied with an instructions for use (ifu) pamphlet.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concluded this event to be due to a manufacturing deficiency.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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: 18486966
• Report Number: 1820334-2024-00053
• Device Sequence Number: 17888827
• Product Code: KGZ
• UDI-Device Identifier: 00827002042674
• UDI-Public: (01)00827002042674(17)251110(10)15064908
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 11/10/2025
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100
• Device Lot Number: 15064908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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