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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: "beginning of the month".Occupation: unknown.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 a neff percutaneous access set was inspected upon arrival at a distribution facility.An unknown particle was noted inside the unopened packaging of the device.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on:27dec2019.Investigation ¿ evaluation.(b)(6) informed cook of an incident involving a neff percutaneous access set.It was reported the device was inspected upon arrival at a distribution facility.An unknown particle was noted inside the unopened packaging of the device.No other adverse effects were reported for this incident.A review of the complaint history, device history record, and quality control of the device, as well as a visual inspection, were conducted during the investigation.The complainant returned one unopened device to cook for investigation.A fiber from an unknown source was found in the pouch.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot records one non-conformance.The recorded non-conformances is related to this incident for foreign matter in the side seal.This affected a quantity of one that was reworked.This is checked 100% in qc before released from packaging.A database search was completed on the complaint lot and no additional complaints were found.There are adequate inspection activities established, objective evidence that the dhr was fully executed and no additional complaints from the same lot.Therefore, it was concluded that there is no evidence that nonconforming product exists in house or in field.The complaint product does not come supplied with an instructions for use (ifu) insert, so a review of the product labeling could not be completed.The device was returned sealed with foreign matter inside.Based on the information provided, the examination of returned product and the results of the investigation, it was concluded that the cause is traced to manufacturing with a quality control deficiency.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.

• 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: 9443821
• MDR Text Key: 176047860
• Report Number: 1820334-2019-03062
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002042674
• UDI-Public: (01)00827002042674(17)220910(10)10003582
• 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: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/10/2022
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100
• Device Lot Number: 10003582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1