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 2012-12-21 for HUDSON ENDOTRACHEAL TUBE, HVT, 7.0, NOVA PLUS V5-10314 manufactured by Teleflex.
[3057386]
The complaint is reported as: the cuff on the tube is deflating and creating leaks during patient use. The cuff had to be reinflated and monitored. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[10365944]
The device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint. The device sample is not available for evaluation, therefore, the complaint could not be confirmed and a root cause could not be established. Manufacturer will continue to monitor and trend related complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2012-00614 |
| MDR Report Key | 2889104 |
| Report Source | 05,06,07 |
| Date Received | 2012-12-21 |
| Date of Report | 2012-12-07 |
| Date of Event | 2012-12-07 |
| Date Mfgr Received | 2012-12-07 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-03-25 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | P. O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINO # 1316,RANCHO EL DESCANSO |
| Manufacturer City | TECATE, B.C. 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ENDOTRACHEAL TUBE, HVT, 7.0, NOVA PLUS |
| Generic Name | ET TUBE |
| Product Code | LNZ |
| Date Received | 2012-12-21 |
| Catalog Number | V5-10314 |
| Lot Number | 01F1200189 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-21 |