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 2011-05-31 for HUDSON ET TUBE, UNCUFFED PED-SOFT 2.5MM 5-30405 manufactured by Teleflex Medical.
[15504308]
The event is reported as: complaint alleges that while suctioning a pt, the nurse felt resistance at the end of the tube. Fearing a blockage, the nurse chose to reintubate the pt. She felt the same resistance. Examination of the tip of et tubes from the same lot # revealed a narrowing which created a feeling of resistance. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[15794728]
Sample has been received by mfr but investigation is incomplete at time of this report. A follow up report will be sent when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2011-00244 |
| MDR Report Key | 2146092 |
| Report Source | 05,06,07 |
| Date Received | 2011-05-31 |
| Date of Report | 2011-05-20 |
| Date of Event | 2011-04-06 |
| Date Mfgr Received | 2011-05-20 |
| Date Added to Maude | 2011-08-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELAINE BURKLE, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| Manufacturer Street | PROLONGACION MISION EUSEBIO KINO #1316, RANCHO EL DESCANSO |
| 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 | HUDSON ET TUBE, UNCUFFED PED-SOFT 2.5MM |
| Generic Name | PED UNCUFFED ET TUBE |
| Product Code | LNZ |
| Date Received | 2011-05-31 |
| Returned To Mfg | 2011-05-27 |
| Catalog Number | 5-30405 |
| Lot Number | 01B1000464 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-31 |