MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-02-12 for CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD 004081-A manufactured by Vyaire Medical, Inc.
[99777155]
(b)(4): vyaire will reach out to customer for sample availability and additional information. If the sample is obtained and further evaluation can be performed an update emdr will be provided.
Patient Sequence No: 1, Text Type: N, H10
[99777156]
The customer reported "we are experiencing melting of the cardinal health o2 bleed-in adapter with use of a bi level humidifier. We cannot replicate this in our test environment. The melting is happening at the nipple and what is most notable is the tapering of the port that restricts the flow of oxygen".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00411 |
| MDR Report Key | 7262957 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-02-12 |
| Date of Report | 2018-02-12 |
| Date of Event | 2018-02-02 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2018-02-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N RIVERWOOD 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 MEX |
| 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 | CONNECTOR U/ADAPIT STR 22MM ID X 22MM OD |
| Generic Name | CONNECTOR, AIRWAY (EXTENSION) |
| Product Code | BZA |
| Date Received | 2018-02-12 |
| Catalog Number | 004081-A |
| Lot Number | 0001129863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 N RIVERQWOOD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-12 |