MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-07-08 for HUDSON ET TUBE, UNCUFFED, PED-SOFT 5-30405 manufactured by Teleflex Medical.
[1561409]
The event is reported as: it was difficult to pass a suction catheter through the et tube during intubation. No injuries reported. Pt's condition is unk.
Patient Sequence No: 1, Text Type: D, B5
[8611868]
Product has not been received for investigation at time of this report. A follow-up investigation report will be sent when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2010-00294 |
| MDR Report Key | 1767824 |
| Report Source | 06 |
| Date Received | 2010-07-08 |
| Date of Report | 2010-06-16 |
| Date of Event | 2010-05-10 |
| Date Mfgr Received | 2010-06-16 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MGR |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334901 |
| Manufacturer Street | PROLONGACION MISION EUSENBIO 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 ET TUBE, UNCUFFED, PED-SOFT |
| Generic Name | PED UNCUFFED ET TUBE |
| Product Code | LNZ |
| Date Received | 2010-07-08 |
| Model Number | NA |
| Catalog Number | 5-30405 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-08 |