MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-09-24 for MALLINCRODT 5-18537 manufactured by Covidien.
[4921658]
Covidien received information from a customer stating that during pre-use testing, the cuff on a combitube would not inflate. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[12176843]
The lot number was asked but unknown. Without the lot number, the date of manufacture cannot be determined. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2014-00849 |
| MDR Report Key | 4113256 |
| Report Source | 01,05,07 |
| Date Received | 2014-09-24 |
| Date of Report | 2014-09-01 |
| Date of Event | 2014-09-01 |
| Date Mfgr Received | 2014-09-01 |
| Date Added to Maude | 2014-10-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE BRAXTON |
| Manufacturer Street | 6135 GUNBARREL AVE. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3038768909 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | AVENIDA HENEQUEN 1181 PARQUE INDUSTRIAL SALVARCAR |
| Manufacturer City | CD. JUAREZ, CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLINCRODT |
| Generic Name | ESOPHAGEAL TRACHEAL TUBE |
| Product Code | CAO |
| Date Received | 2014-09-24 |
| Model Number | 5-18537 |
| Catalog Number | 5-18537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | AVENIDA HENEQUEN 1181 PARQUE INDUSTRIAL SALVARCAR CD. JUAREZ, CHIHUAHUA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-24 |