MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-10-02 for COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER C-CAE-11.0-100-DLT-EF-ST manufactured by Cook Inc.
[122375909]
Pma/510(k) #: exempt. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[122375910]
It was reported a cook double lumen extra firm soft tipped airway exchange catheter was used for an endotracheal tube exchange from spiral trachea tube (8. 0 mm) to trachea tube (8. 5 mm) on a patient under respiratory management. The exchange catheter was inserted into the tracheal tube and upon attempting to remove the spiral trachea tube, it could not be removed. The customer manipulated the exchange catheter in order to remove the trachea tube and in the process, the catheter ruptured. A segment of the catheter, approximately 25 cm, remained in the pharynx and was retrieved using forceps. The patient was successfully intubated. As reported, the customer did not use excessive force on the device while manipulating it to remove the tracheal tube and the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02822 |
| MDR Report Key | 7927446 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-02 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-09-09 |
| Date Mfgr Received | 2018-10-24 |
| Device Manufacturer Date | 2018-04-18 |
| Date Added to Maude | 2018-10-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER |
| Generic Name | LRC CHANGER, TUBE, ENDOTRACHEAL |
| Product Code | LRC |
| Date Received | 2018-10-02 |
| Returned To Mfg | 2018-09-20 |
| Model Number | NA |
| Catalog Number | C-CAE-11.0-100-DLT-EF-ST |
| Lot Number | 8781438 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-02 |