MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-19 for STYLET NEONATAL, FOR ETT SIZES 2.5 - 4 S5000N manufactured by Vyaire Medical, Inc.
[97848257]
Vyaire has reached out to customer to provide the complaint device for further investigation. At this time we are currently waiting for the sample. If the customer provides the sample for further investigation or additional information is obtained, vyiare will provided a follow up emdr.
Patient Sequence No: 1, Text Type: N, H10
[97848258]
The customer report "while assisting in a room today of a neonate intubation for pyloric stenosis the stylet was stuck post intubation in the et tube. When the provider attempted to remove the stylet, the blue coating stuck to the inside of the et tube and remained in the et tube. The et tube was immediately removed and no breaths were given".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00409 |
| MDR Report Key | 7208599 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-19 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-01-05 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-01-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STYLET NEONATAL, FOR ETT SIZES 2.5 - 4 |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-01-19 |
| Returned To Mfg | 2018-02-15 |
| Catalog Number | S5000N |
| Lot Number | 0001153099 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 N RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-19 |