MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-10 for NEO-VERSO 'Y' NEONATAL Y AIRWAY ACCESS ADAPTER CSC300 manufactured by Vyaire Medical.
[188823016]
The customer indicated that the suspected sample is available to return for investigation. At this time, the suspect device has not received yet. Investigation is still ongoing. Therefore, no root cause could be determine yet. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188823017]
The customer reported that the csc300 adapter verso airway sz2. 0-4. 0 et tubes's adapter has a crack in multiple places. This was seen during patient use and they replaced the device. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00064 |
| MDR Report Key | 9576447 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-10 |
| 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 | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION 85 INDUSTRIAL MEXICALI |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO-VERSO 'Y' NEONATAL Y AIRWAY ACCESS ADAPTER |
| Generic Name | CLOSED SUCTION CATHETERS AND ADAPTORS |
| Product Code | CAI |
| Date Received | 2020-01-10 |
| Model Number | NEO-VERSO 'Y' NEONATAL Y AIRWAY ACCESS ADAPTER |
| Catalog Number | CSC300 |
| Lot Number | 201811230001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-10 |