MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-02 for MALLINCKRODT 5-18541 manufactured by Covidien.
[25494604]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25494605]
It was reported that prior to use, there was an inflation/deflation issue with the cuff. There is no report of patient involvement and no report of serious injury or death associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[43620488]
(b)(4). The manufacturing guidelines and controls were reviewed and found effective to detect this type of failure mode. The reported malfunction is not related to the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2015-00773 |
| MDR Report Key | 5051322 |
| Date Received | 2015-09-02 |
| Date of Report | 2015-08-03 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2012-12-06 |
| Date Added to Maude | 2015-09-02 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| 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 | MALLINCKRODT |
| Generic Name | ESOPHAGEAL TRACHEAL AIRWAY |
| Product Code | CAO |
| Date Received | 2015-09-02 |
| Returned To Mfg | 2015-11-05 |
| Model Number | 5-18541 |
| Catalog Number | 5-18541 |
| Lot Number | 12L0688JZX |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-09-02 |