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

Model Number N/A

Device Problem Unraveled Material (1664)

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

Event Type  malfunction  

Event Description

It was reported that the wire guide included in the neff percutaneous access set unraveled during an insertion procedure on an unknown patient.The wire was able to be removed in its entirety.The patient did not experience any adverse effects or require additional procedures due to this occurrence.Additional information regarding event details has been requested but is currently unavailable.

Manufacturer Narrative

E3 - occupation: acting charge nurse manager.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 Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d9, h3 investigation ¿ evaluation christchurch hospital located in christchurch, new zealand reported an event involving a neff percutaneous access set (rpn: npas-100-rh, lot 15162137).During the insertion process there was difficulty with the wire guide supplied with the device.The wire guide was removed and was found to be unraveled.No part of the device remained within the patient.The patient did not require any additional procedures or experience any adverse effects due to this occurrence.Cook became aware of this event on (b)(6) 2023.Reviews of the complaint history, device history record (dhr), and quality control were conducted during the investigation.The customer did not return the complaint device to the manufacturer for investigation.Therefore, no physical examinations were able to be performed.However, a document-based investigation evaluation was completed.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 dhr for the reported complaint device lot (15162137) revealed a non-conformance relevant to the failure mode.The nonconforming products were scrapped.All of the remaining devices in the lot underwent quality control activities.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The neff percutaneous access set (rpn: npas-100-rh, lot 15162137) device is not supplied with instructions for use (ifu).However, the wire guide holder supplied with the device is equipped with a label attached indicating not to withdraw or manipulate the wire guide through the needle.Based on the available information, no product returned, and the results of the investigation, a definitive root cause was unable to be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the associated 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 or that a death or serious injury occurred; nor is it admission 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
• 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: 17226781
• MDR Text Key: 318377498
• Report Number: 1820334-2023-00849
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002104600
• UDI-Public: (01)00827002104600(17)260112(10)15162137
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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-RH
• Device Lot Number: 15162137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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