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

Model Number	G48303
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Similar to device under pma/510(k) k161813.Summary of investigational findings: the investigation is based on event description and the unused device returned under (b)(4).It was reported that the stylet does not meet the demands of a difficult intubation; semi rigid, anterior articulation, and too flexible and malleable.The actual complaint device was not returned, but an unopened and unused device from the same lot was returned under (b)(4) and an investigation of the returned device revealed a smooth surface and no signs of degradation or any material defects.Therefore, it would be inappropriate to speculate at what may or may not have caused the frova device to become semi rigid and too flexible and malleable as reported.It is noted that the frova device was reportedly "stored in the operating theatre with air conditioning", but also that the "bougie suffered with the canicule".According to the instructions for use the device must be stored in a dark, dry, cool place.No evidence to suggest that the device was not manufactured according to specifications.Cook medical will continue to monitor for similar events.
Event or Problem Description
Description of event according to initial reporter: this stylet does not meet the demands of a difficult intubation, semi rigid, anterior articulation, too flexible and malleable.The bougie doesn't meet the requirements of a difficult intubation.Semi stiffness, anterior bending, too soft and malleable.Vital risk in case of difficult airway intubation.The bougie crouches in the other direction as it touches an obstacle.If you couldn't intubate , you have a risk of death of the patient, you have to use other device to help you: videolaryngoscopy, fastrack, melker cricothyrotomies set ¿it happened twice¿.Patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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
• MDR Report Key: 9353343
• Report Number: 3002808486-2019-01847
• Device Sequence Number: 470390
• Product Code: BTR
• UDI-Device Identifier: 00827002483033
• UDI-Public: (01)00827002483033(17)220501(10)E3848458
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: G48303
• Device Catalogue Number: C-CAE-14.0-70-FIC
• Device Lot Number: E3848458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1