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)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Occupation: director of logistics.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 a cook neff percutaneous access set was contaminated.A particle was found inside the packaging of the device by the distributor.No patient contact was made.Therefore, no adverse effects occurred.
Event or Problem Description
No additional information regarding patient and/or event details 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 ifs miami (colombia) contacted cook on (b)(6) 2023 concerning a neff percutaneous access set (rpn: npas-104-rh-nt, lot# 15037452).The distributor found foreign matter in the package on (b)(6) 2023.No patient contact was made.Reviews of the documentation, including the complaint history, device history record and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One unopened neff percutaneous access set was returned for evaluation.Upon a visual inspection of the device, a foreign particle was found near the distal tip of the dchn needle.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that process steps were identified to ensure this nonconformance does not leave the house.A review of the device history record (dhr) for lot 15037452 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook was unable to review product labeling, as this device is not supplied with an instruction for use (ifu) pamphlet.Evidence gathered from a review of the dmr, dhr and device failure analysis suggests that the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive cause for the failure could be attributed to a quality control deficiency.The appropriate personnel have been notified.Per the risk assessment no further action is required.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: 16558821
• Report Number: 1820334-2023-00266
• Device Sequence Number: 17498560
• Product Code: KGZ
• UDI-Device Identifier: 00827002105461
• UDI-Public: (01)00827002105461(17)251025(10)15037452
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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 Expiration Date: 10/25/2025
• Device Model Number: N/A
• Device Catalogue Number: NPAS-104-RH-NT
• Device Lot Number: 15037452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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