MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-07-30 for HUDSON ISIS SUBGLOTTIC ENDOTRACHEAL TUBE 5-13017 manufactured by Teleflex Medical.
[1359721]
The event is reported as: there was a small hole noted on the isis et tube. A leak was noticed as well. The et tube was being used on a pt. The pt was extubated and re-intubated. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8793184]
Additional info has been requested to determine if the device sample is available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2010-00341 |
| MDR Report Key | 1786201 |
| Report Source | 05,06,07 |
| Date Received | 2010-07-30 |
| Date of Report | 2010-07-13 |
| Date of Event | 2010-07-13 |
| Date Mfgr Received | 2010-07-13 |
| Date Added to Maude | 2011-01-18 |
| 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 | ANGELA BROWN, MGR |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINO # 1316,RANCHO EL DESCANSO |
| Manufacturer City | TECATE, B.C., C.P. 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ISIS SUBGLOTTIC ENDOTRACHEAL TUBE |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 2010-07-30 |
| Model Number | NA |
| Catalog Number | 5-13017 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-30 |