MAUDE Adverse Event Report: COOK INC TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; DQY CATHETER, PERCUTANEOUS

Model Number N/A

Device Problems Delivered as Unsterile Product (1421); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation: unknown.Pma/510(k) #: not exempt, preamendment.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 a foreign particle was found inside the packaging of a triple lumen polyurethane central venous catheter set during inspection.In photos provided by the complainant, the foreign particle appears to be a small, unidentified, black flake.No adverse effects have been reported as a result of this event.

Event Description

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

Manufacturer Narrative

Correction: h6- device code.H6 ¿ method code: (4114) device not returned.Investigation / evaluation: a review of the documentation including the complaint history, device history record (dhr), instructions for use (ifu) and quality control, as well as photos of the device, was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos of the device were provided to cook for analysis.The photos confirm a foreign particle within the sterile barrier.The seal was complete with no damage to the packaging.Additionally, a document-based investigation evaluation was performed.Cook has concluded that 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 dhr for the complaint device lot: (9910210) found no recorded non-conformances.A database search revealed this to be the only event associated with the provided complaint device lot.There is no evidence that suggests that non-conforming product exists either in house or in field.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of our investigation, a root cause was traced to a deficiency in manufacturing and quality control.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: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9397029
• MDR Text Key: 184740228
• Report Number: 1820334-2019-02993
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00827002029378
• UDI-Public: (01)00827002029378(17)220726(10)9910210
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/26/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J
• Device Lot Number: 9910210
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1