MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-03-08 for RUSCH AGT NASAL PERFORMED ET TUBE, 7.0MM 111781070 manufactured by Teleflex Medical.
[3196998]
The event is reported as: the cuff of the endotracheal tube leaking during intubation. The tube was removed and the pt re-intubated. The cuff of the endotracheal tube was no pre-inflated. No report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
[10555749]
The device sample was not returned for eval at the time of the report.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 8040412-2013-00051 |
MDR Report Key | 3000148 |
Report Source | 01,05,06,07 |
Date Received | 2013-03-08 |
Date of Report | 2013-02-26 |
Date of Event | 2013-02-26 |
Date Mfgr Received | 2013-02-26 |
Date Added to Maude | 2013-05-14 |
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 | MARGIE BURTON, RN |
Manufacturer Street | P.O. BOX 12600 |
Manufacturer City | DURHAM NC 27709 |
Manufacturer Country | US |
Manufacturer Postal | 27709 |
Manufacturer Phone | 9194334965 |
Manufacturer G1 | TELEFLEX MEDICAL |
Manufacturer Street | P.O. BOX 28 |
Manufacturer City | KAMUNTING, PERAK WEST MALAYSIA 34600 |
Manufacturer Country | MY |
Manufacturer Postal Code | 34600 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | RUSCH AGT NASAL PERFORMED ET TUBE, 7.0MM |
Generic Name | CUFFED ENDOTRACHEAL TUBE |
Product Code | BSK |
Date Received | 2013-03-08 |
Catalog Number | 111781070 |
Lot Number | 12JG17 |
Operator | OTHER |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX MEDICAL |
Manufacturer Address | PERAK MY |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-03-08 |