MAUDE Adverse Event Report: WILLIAM COOK EUROPE FROVA INTUBATING INTRODUCER; BTR TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	C-CAE-14.0-70-FIC
Medical Device Problem Codes	Component Incompatible (1108); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): k161813.Investigation is still in progress.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Description of event according to initial reporter: blue plastic came off the frova bougie while intubating.Patient outcome: no additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: blue plastic came off the frova device while intubating with an unknown single lumen tube.No unintended part of device remained inside the patient and no adverse effect of the patient was reported.The frova introducer was returned and so were two small fragments of the blue introducer material.The introducer appeared unused, but two shavings were noted and some material, likely gel, was found in the side-hole.Based on these findings the exact reason for the frova material to come off during intubation cannot be determined.But considering the inner diameter of the endotracheal tube is unknown and the fact that reportedly the frova introducer nor the endotracheal tube was lubricated prior to use the difficulties are considered of no fault to the frova introducer.According to the instructions for use the frova introducer it is designed for placement of a single lumen endotracheal tube whose inner diameter is 6mm or larger.Furthermore, the ifu also warn and instruct to lubricate the catheter introducer and the endotracheal tube before use and that care must be taken when introducing/removing the catheter introducer from the endotracheal tube, as contact with sharp edges on the internal surface of the endotracheal tube may cause small fragments to be shaved off the introducer.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FROVA INTUBATING INTRODUCER
• Common Device Name: BTR TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17639183
• Report Number: 3002808486-2023-00227
• Device Sequence Number: 5590456
• Product Code: BTR
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)260516(10)E4407939
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2026
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: E4407939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown