MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-12-15 for HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5 5-30405 manufactured by Teleflex Medical.
[2429341]
The event is reported as: complaint was reported as the following: alleged issue: the ballard suction catheter is getting stuck at the end of the sheridan 2. 5 ctt. On the inside of ett tube directly above the murphy eye there is some sort of obstruction. This obstruction blocks the suction catheter from going down the ett and gets it stuck when pulling the suction catheter back. No pt injury reported. Pt current condition is unk.
Patient Sequence No: 1, Text Type: D, B5
[9597387]
The device sample was not received by the mfr at the time of this report. A f/u report will be sent when completion of investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2011-00479 |
| MDR Report Key | 2410646 |
| Report Source | 06,07 |
| Date Received | 2011-12-15 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-11-28 |
| Date Mfgr Received | 2011-12-02 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-04-06 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer Street | KINO#1316, RANCHO EL DESCANSO PROLONGACION MISION EUSEBIO |
| Manufacturer City | TECATE, B.C. C.P.214 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | C.P. 2147 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ET TUBE, UNCUFFED, PED-SOFT, 2.5 |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | LNZ |
| Date Received | 2011-12-15 |
| Catalog Number | 5-30405 |
| Lot Number | 01H100577 |
| 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 | 2011-12-15 |