MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for FROVA INTUBATING INTRODUCER C-CAE-14.0-70-FII manufactured by William Cook Europe.
[185666901]
Manufacturers ref# (b)(4). Pma/510(k): k161813. Investigation is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[185666902]
Description of event according to initial reporter: the catheter broke inside the patient. Patient was being intubated prior to egd procedure. Frova intubating introducer broke during removal from the patients airway leaving about 20 cm of the introducer in the patients lung. The et tube was successfully placed and the patients airway was maintained while attempts were made to remove the object from the patient. The object was successfully removed after several attempts. Patient outcome: no adverse effects was reported on the patient due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808486-2020-00373 |
| MDR Report Key | 9896405 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-07 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2017-12-13 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. THOMAS HESSNER KIRK |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-4632 |
| Manufacturer Phone | 56868686 |
| Manufacturer G1 | WILLIAM COOK EUROPE |
| Manufacturer Street | SANDET 6 |
| Manufacturer City | BJAEVERSKOV DK-4632 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | DK-4632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FROVA INTUBATING INTRODUCER |
| Generic Name | BTR TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-30 |
| Catalog Number | C-CAE-14.0-70-FII |
| Lot Number | E3666617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILLIAM COOK EUROPE |
| Manufacturer Address | SANDET 6 BJAEVERSKOV 4632 DA 4632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |