MAUDE Adverse Event Report: COOK INC MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number G06425

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

It was reported, upon receipt of a multi-sideport dual check valve catheter infusion set at the distribution center, a piece of hair was observed inside of the sealed, primary packaging.This observation was made upon incoming inspection of the device.It was not used for patient care.

Event Description

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

Manufacturer Narrative

Investigation - evaluation a review of the complaints history, device history record, quality control, and instructions for use (ifu) of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The product ifu instructs the user the user no to use the product if there if doubt as to whether the product is sterile an advises the user to inspect the product to ensure no damage has occurred upon removal from package.Based on the information provided, no product returned and the results of our investigation, it has been concluded the cause of this event is manufacturing deficiency related.Appropriate measures have been initiated to address this failure mode.We 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: MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8640245
• MDR Text Key: 146079506
• Report Number: 1820334-2019-01286
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002064256
• UDI-Public: (01)00827002064256(17)211207(10)9205706
• 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: 05/31/2019

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: 12/07/2021
• Device Model Number: G06425
• Device Catalogue Number: MCIS-5.0-35-130-15.0
• Device Lot Number: 9205706
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1