FROVA INTUBATING INTRODUCER
Report
- Report Number
- 3002808486-2022-00994
- Event Type
- Injury
- Date Received
- October 19, 2022
- Report Date
- January 18, 2023
- Manufacturer
- WILLIAM COOK EUROPE
- Product Code
- BTR
- UDI-DI
- 00827002483033
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MANUFACTURER REF# (B)(4). INITIAL REPORTER OCCUPATION: PURCHASING PORTFOLIO MANAGER. SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K161813. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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.
MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A SCRAPE OFF FROM THE CATHETER ENDED UP IN PATIENT¿S AIRWAYS WHEN A TUBE WAS PLACED OVER. THE SCRAPE OFF WAS RETRIEVED AND DID NOT AFFECT THE PATIENT OUTCOME. THE FROVA INTRODUCER AND THE SCRAPE OFF FROM THE FROVA WERE RETURNED FOR DEVICE EVALUATION. THE FROVA INTRODUCER WAS RETURNED KINKED. A SCRAPE MARK WAS FOUND ON THE INTRODUCER NEAR THE PROXIMAL END. SQUEEZE MARKS AND AN INDENTATION WERE OBSERVED NEAR THE PROXIMAL END. THE TIP WAS WITHOUT ANY OBSERVED NONCONFORMANCES. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE FINAL RELEASE, 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. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. ACCORDING TO THE INSTRUCTIONS FOR USE THE 14.0 FRENCH FROVA INTRODUCER HAS BEEN DESIGNED FOR PLACEMENT OF A SINGLE LUMEN ENDOTRACHEAL TUBE WHOSE INNER DIAMETER IS 6 MM OR LARGER. FURTHERMORE, THE IFU WARN THAT THE TUBE AND THE INTRODUCER MUST BE LUBRICATED BEFORE USE AND THAT CARE MUST BE TAKEN WHEN INTRODUCING/REMOVING THE 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 CATHETER INTRODUCER DURING INTRODUCTION/REMOVAL. DESPITE SEVERAL ATTEMPTS NO INFORMATION AS TO THE USE OF A SINGLE OR A DOUBLE LUMEN ENDOTRACHEAL TUBE COULD BE OBTAINED. THEREFORE, BASED ON THE PROVIDED INFORMATION AND THE DEVICE EVALUATION AN EXACT CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. 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.
ACCORDING TO INITIAL REPORTER: PIECE OF PLASTIC SHEARED OFF WHEN TUBE PLACED OVER, ENDING UP IN PATIENT'S AIRWAY.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2938397 | FROVA INTUBATING INTRODUCER | BTR TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | WILLIAM COOK EUROPE | G48303 | E3908347 | 00827002483033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |