MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PRESSURE MONITORING SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

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

(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 during an inspection, a piece of hair was observed inside the primary packaging of the single lumen pressure monitoring set.The device did not make patient contact.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Investigation - evaluation: a review of documentation including the complaint history, device history record, instructions for use (ifu), quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination could not be performed.However, the distribution center provided images of the device.The images confirmed an unknown dark fiber sealed within the packaging tray.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file found that proper risk controls are in place to identify these issues.The document ensures that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for lot 9219048 revealed no nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no returned product and the results of our investigation, a definitive root cause can be traced to manufacturing and a quality control deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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: SINGLE LUMEN PRESSURE MONITORING SET
• Type of Device: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8675793
• MDR Text Key: 147232887
• Report Number: 1820334-2019-01399
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00827002028388
• UDI-Public: (01)00827002028388(17)211008(10)9219048
• 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: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/08/2021
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-250
• Device Lot Number: 9219048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1