MAUDE Adverse Event Report: COOK INC FROVA INTUBATING INTRODUCER; LRC CHANGER, TUBE, ENDOTRACHEAL

Catalog Number C-CAE-8.0-35-FII

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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 a frova intubating introducer was found broken after withdrawal from the endotracheal tube (ett).The introducer was used during a repair of lumbosacral meningomyelocele on a (b)(6) old neonate.The patient was intubated with a 3mm ett loaded over an 8 french introducer due to an anticipated "difficult airway" after direct laryngoscopy and lubrication with water soluble gel, the ett loaded on the frova was introduced through the vocal cords.Little resistance was felt during railroading of the ett.When the introducer was withdrawn after intubating, the anesthesiologist noticed that the curved tip was broken and missing.The ett was immediately removed from the trachea and examined, and the broken segment of the introducer was found within the distal tip of the ett.The patient was ventilated with a face mask and reintubated with another ett loaded over a metal stylet.On assessment, it was found the introducer was 5 years old, while the manufacturer recommendation for the device is 3 years.

Event Description

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

Manufacturer Narrative

Investigation/evaluation: a review of the documentation including the complaint history, instructions for use (ifu), quality control and trends was conducted during the investigation.The visual inspection of the complaint device could not be completed, as the device was not returned for inspection.However, a document based investigation evaluation was performed.A review of the device master record found that the device aspect in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.A review of the device history record could not be completed due to a lack of lot information from the user facility.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The ifu states the following instructions 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, cook 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 inspection of the product, and the results of the investigation, a definitive cause was not established.The device was used 2 years past the manufacturer recommended shelf life, so it is feasible to suggest that using an expired device may have contributed to the separation of the introducer.The appropriate personnel have been notified.Per the quality engineering 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: FROVA INTUBATING INTRODUCER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9261640
• MDR Text Key: 174313621
• Report Number: 1820334-2019-02741
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-CAE-8.0-35-FII
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA