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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported that a hair was identified within the packaging of a neff percutaneous access set.No contact with the patient was made.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): phone: +(b)(6).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.

Manufacturer Narrative

Investigation evaluation: it was reported to cook that a hair was identified within the packaging of a neff percutaneous access set.The device did not make contact with the patient.Reviews of documentation including the complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The unused device was returned to cook for investigation.The device failure analysis determined a hair-like strand was sealed within the inner needle pouch.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 dhrs for the reported complaint device lot and the related subassembly lots revealed no related nonconformances.A database search identified no other events reported for foreign matter.Cook was unable to review product labeling as instructions for use (ifu) are not provided with this product.The information gathered upon review of the returned product confirmed the device was manufactured out of specification.However, review of the dmr and dhr showed no evidence of additional nonconforming product in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, a root cause of the event has been traced to a manufacturing and quality control 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.

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Type of Device: 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: 17671381
• MDR Text Key: 322523027
• Report Number: 1820334-2023-01184
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)260414(10)15391453
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-NT
• Device Lot Number: 15391453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1