MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for MALLINCKRODT manufactured by Covidien.
[59455079]
(b)(4). Patient information as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report. The customer did not retain the model and lot number which determines the date of manufacture and the 510k.
Patient Sequence No: 1, Text Type: N, H10
[59455080]
The connector end of the endotracheal tube had stretched out and kept disconnecting from the ventilator, which caused a safety issue for the patient. A larger connector was tried, but the same disconnections continued to occur. The tube needed to be changed out. The tube was discarded. The patient has been discharged to an assisted living facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2016-00944 |
| MDR Report Key | 6087472 |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-17 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2016-11-08 |
| 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 | RAY MAROOFIAN |
| Manufacturer Street | 2101 FARADAY AVE |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7606035334 |
| 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 | 0 |
| Brand Name | MALLINCKRODT |
| Generic Name | UNSPECIFIED ENDOTRACH TUBE |
| Product Code | BSK |
| Date Received | 2016-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2016-11-08 |