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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

Customer (person): phone: (b)(6).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 prior to inserting a neff percutaneous access set during a percutaneous nephrolithotomy (pcnl) procedure, the user discovered the set was "faulty".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device was received by cook on 21jun2022 and it was noted the hub had separated from the sheath, thus prompting this report.

Event Description

No new patient and/or event information was provided.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation: tallaght hospital (ireland) contacted cook concerning a npas-100-nt set from lot# 14426602.The customer stated that during a procedure the hub separated from the sheath.The failure was noted prior to use.The procedure was a percutaneous nephrolithotomy (pcnl) procedure.The procedure was completed with another set.The patient did not require additional procedures or experience any adverse effects due to this occurrence.Reviews of the documentation including the complaint history, device history record, manufacturing instructions, quality control procedures, as well as a visual inspection of the returned product, were conducted during the investigation.One prior to use device was received for evaluation.Upon a visual inspection, it was noted that the sheath came out of the hub.A split in the sheath could cause this failure, and there is a split near the part of the sheath where it is separated.Additionally, a document based investigation evaluation was performed.A review of the device master record (dmr) was conducted.This product is 100% inspected for non-conformances during the manufacturing process.A review of the device history record (dhr) for lot 14426602 showed zero related non-conformances.A database search revealed no other complaints under this lot number at the time of this investigation.A review of product labeling could not be conducted because this product is not supplied with an instructions for use (ifu) pamphlet.Based on the dmr, the dhr, and the device failure analysis, cook found evidence the product was manufactured out of specification.However, review of the dhr and additional related lots showed that there is no evidence of additional non-conforming material in house or in the field.The customer stated that during a procedure the hub separated from the sheath.Evaluation showed a split at the flare of the sheath which came out of the hub.This split may have caused the observed separation; this failure can be attributed to a manufacturing production and quality control deficiency.The appropriate internal personnel have been notified.Per the 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.

• 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: 14829830
• MDR Text Key: 294949154
• Report Number: 1820334-2022-01118
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)241216(10)14426602
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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: 14426602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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