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

Model Number G10544

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the packaging of a neff percutaneous access set was not sealed prior to use.No patient contact was made.

Manufacturer Narrative

Investigation ¿evaluation.It was reported to cook, by nanchang xigema medical equip., in china, that the packaging of a neff percutaneous access set, rpn: npas-100-rh-nt, from lot 13718754, was not sealed.This was identified at a distribution center before the device made it to an end user.Reviews of the device history record (dhr), complaint history, manufacturing instructions (mi), specifications, and quality control procedures of the device, as well as visual inspection of the returned product were conducted during the investigation.One device was returned to cook for evaluation.The packaging was found to be unsealed, with no evidence of adhesive.Cook has concluded that the device was not manufactured to specification.Additionally, a document-based investigation evaluation was performed.A device master record (dmr) review was performed, and device specifications and quality control procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for lot 13718754 revealed no related non-conformances.A database search revealed no other complaints have been reported for the device lot.A review of other, similar, devices manufactured on the same day by the same personnel in additional lots revealed no other complaints.Based on the available information, cook has concluded that there is evidence the device was manufactured out of specification, but that there are not any other nonconforming devices in house or out in the field.There are no instructions for use (ifu) associated with this device.Based on the available information, inspection of the returned device, and the results of the investigation, cook has concluded that quality control deficiency contributed to the failure mode.The appropriate manufacturing personnel, package sealers and quality control inspectors, were retrained in response to this occurrence.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering 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 the patient and/or event 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: 11819073
• MDR Text Key: 253174773
• Report Number: 1820334-2021-01327
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)240127(10)13718754
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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 Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: G10544
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 13718754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2021
• 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