MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2010-08-11 for SHERIDAN HVT ENDOTRACHEAL TUBE 8.0MM 5-10316 manufactured by Teleflex Medical.
[1573881]
The event is reported as: defective pilot balloon. After intubation, one of the components seemed to have come off from the pilot balloon so that the cuff could not be deflated properly. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[8669613]
Product has not yet been received by manufacturer for evaluation, therefore, investigation report is incomplete at this time. A follow-up investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2010-00371 |
| MDR Report Key | 1804286 |
| Report Source | 01,06,08 |
| Date Received | 2010-08-11 |
| Date of Report | 2010-07-28 |
| Date of Event | 2010-06-07 |
| Date Mfgr Received | 2010-07-28 |
| 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, MANAGER |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | KINO #1316, RANCHO EL DESCANSO PROLONGACION MISION EUSENBIO |
| Manufacturer City | TECATE, B.C. C.P.214 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | C.P. 2147 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHERIDAN HVT ENDOTRACHEAL TUBE 8.0MM |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 2010-08-11 |
| Model Number | NA |
| Catalog Number | 5-10316 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| 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 | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-11 |