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

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: quality trainee.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 the distributor found a piece of hair inside the primary package of a neff percutaneous access set.The device did not reach a user facility or make patient contact.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, device history record, and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, the customer supplied images to cook for review.From the images, it is confirmed that a hair-like filament was noted in the seal of the package.From this, the product is confirmed to be packaged out of specification.Additionally, a document based investigation evaluation was performed.Cook completed a review of the product device master record (dmr), and has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also completed a review of the device history record (dhr) for the lot of the complaint device.From the review, one nonconformance for foreign matter was recorded.Further investigation into the operator and inspector for the affected lot was performed.From this investigation, three additional lots were found to have been produced on the same day for the same rpn.Of these three additional lots, one additional nonconformance was recorded for a different operator and inspector, suggesting there is no operator/inspector specific issue.All products undergo 100% inspection for foreign matter within the package, and a software complaint search for the reported and additional lots found no additional complaints from the field.Thus, there is no evidence of additional nonconforming product from either of these lots in house or in the field.Based on the information provided, no inspection of returned product and the results of the investigation, a definitive cause could be established.Cook has concluded that a quality deficiency contributed to this incident.The appropriate personnel have been notified.Per the quality engineering 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.

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
• MDR Report Key: 8640246
• MDR Text Key: 146371660
• Report Number: 1820334-2019-01291
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)210727(10)9051135
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/27/2021
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 9051135
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1