MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-22 for FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER BLUE BOUGIE manufactured by Green Field Sourcing, Inc..
[118141722]
Et tube introducer tip broke off during use. Tip was able to be retrieved, with no injury to the pt. In f/u with the mfr, it was stated that these items have a shelf-life of approx 3 years, however, packaging does not have an expiration date. We estimate this device was in storage beyond this 3 year mark. We have started manually marking items with an expiration date, however, feel this should be part of the packaging.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079348 |
| MDR Report Key | 7809478 |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-19 |
| Date Added to Maude | 2018-08-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FLEX-GUIDE ENDOTRACHEAL TUBE INTRODUCER BLUE BOUGIE |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-08-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREEN FIELD SOURCING, INC. |
| Manufacturer Address | AUSTIN TX 78737 US 78737 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-22 |