MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-08-18 for HUDSON SHERIDAN HVT ENDOTRACHEAL TUBE 7.0MM 5-10314 manufactured by Teleflex Medical.
[1382012]
The event is reported as: the cuff would not stay inflated. Defect found during a pretest. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[8716843]
At this time, it is unknown if a sample will be sent back for investigation. A follow-up investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2010-00383 |
| MDR Report Key | 1817189 |
| Report Source | 06 |
| Date Received | 2010-08-18 |
| Date of Report | 2010-08-06 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2010-08-06 |
| Device Manufacturer Date | 2009-01-01 |
| 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 | MICHAEL TAGGART, VP |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM 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. 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 SHERIDAN HVT ENDOTRACHEAL TUBE 7.0MM |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 2010-08-18 |
| Model Number | NA |
| Catalog Number | 5-10314 |
| Lot Number | 01K0800139 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| 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 | 2010-08-18 |