MAUDE Adverse Event Report: COOK INC ENK OXYGEN FLOW MODULATOR SET

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Device product code: bza.Customer (person): (b)(6).Occupation: ward manager.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 an enk oxygen flow modulator set was inspected prior to use.A hair was noted inside the unopened package in inventory.No other adverse effects were reported.

Manufacturer Narrative

Investigation ¿ evaluation.It was reported that foreign matter was noted in an enk oxygen flow modulator set (c-efms-100) from lot 10245408.Cook became aware of this event on (b)(6) 2021 upon being notified by (b)(6) hospital.The fiber was noted in inventory and the device was not used.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control were conducted during the investigation.The complaint device was not returned to cook for investigation.However, photos were provided showing a dark fiber within the packaging which suggests that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Additionally, four other device lots leaving quality control within two weeks of the complaint lot were reviewed and no complaints or nonconformances were noted from these lots.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: how supplied: supplied sterilized by ethylene oxide gas in peel-open packages sterile if package is unopened or damaged.Do not use the product if there is doubt as to whether the product is sterile upon removal from package, inspect to ensure no damage has occurred.Based on the available information, no product returned, and the results of the investigation, cook has concluded that a manufacturing deficiency and quality control deficiency contributed to the failure mode.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.

Event Description

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

• Brand Name: ENK OXYGEN FLOW MODULATOR SET
• 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: 11569987
• MDR Text Key: 264790374
• Report Number: 1820334-2021-01013
• Device Sequence Number: 1
• Product Code: BZA
• UDI-Device Identifier: 00827002123984
• UDI-Public: (01)00827002123984(17)230105(10)10245408
• 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: 01/31/2022

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: 01/05/2023
• Device Model Number: N/A
• Device Catalogue Number: C-EFMS-100
• Device Lot Number: 10245408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2020
• 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