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 2013-03-12 for RUSCH AGT NASAL PREFORMED ET TUBE, 7.0MM 111781070 manufactured by Teleflex Medical.
[3301285]
The event is reported as: the cuff of the endotracheal tube leaked during intubation. The tube was removed and the pt re-intubated. The cuff of the endotracheal tube was not pre-inflated. No report of pt injury.
Patient Sequence No: 1, Text Type: D, B5
[10677002]
The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2013-00053 |
| MDR Report Key | 3004590 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-03-12 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-02-26 |
| Date Mfgr Received | 2013-02-26 |
| Date Added to Maude | 2013-05-15 |
| 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 | PO 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 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 PREFORMED ET TUBE, 7.0MM |
| Generic Name | CUFFED ENDOTRACHEAL TUBE |
| Product Code | BSK |
| Date Received | 2013-03-12 |
| Catalog Number | 111781070 |
| Lot Number | 12GG44 |
| 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 | 2013-03-12 |