MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-03-11 for MALLINCKRODT BRONCHO-CATH manufactured by Covidien, Formerly Tycohealthcare.
[1483667]
In 10 minutes of use, air leakage occurred. Test prior to use: yes. Pt involvement: yes. Pt harm or injury: no. Reintubation: yes.
Patient Sequence No: 1, Text Type: D, B5
[8442569]
The sample is currently in transit to the mfg plant for analysis. If significant info is identified, a summary of the sample analysis will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2010-00488 |
| MDR Report Key | 1631298 |
| Report Source | 01,06 |
| Date Received | 2010-03-11 |
| Date of Report | 2010-02-14 |
| Date of Event | 2010-02-01 |
| Date Mfgr Received | 2010-02-14 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2010-03-18 |
| 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 | HOLLY GOMES, SUPERVISOR |
| Manufacturer Street | 5870 STONERIDGE DR SUITE 6 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634612 |
| Manufacturer G1 | COVIDIEN, FORMERLY TYCOHEALTHCARE |
| Manufacturer City | CORNAMADDY, ATHLONE |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLINCKRODT |
| Generic Name | BRONCHO-CATH LEFT W/CPAP SYSTEM |
| Product Code | BYE |
| Date Received | 2010-03-11 |
| Catalog Number | BRONCHO-CATH |
| Lot Number | 2009094160 |
| ID Number | RX201002-1760 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY TYCOHEALTHCARE |
| Manufacturer Address | ATHLONE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-11 |