MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-03-28 for VALVE ONE-WAY DISPOSABLE 001800 manufactured by Carefusion.
[1958639]
Gasket valve dislodged from assembly and patient inhaled. Patient required a bronchoscopy.
Patient Sequence No: 1, Text Type: D, B5
[9224764]
The samples received were unused samples. The samples were evaluated according to our inspection procedure and it was determined that the three pieces of this product code are correctly assembled. In addition, the valve and gasket were dimensionally inspected and found within specification. Therefore, we are unable to confirm the issue reported with the samples provided. The device history record for the lot reported was evaluated for any issues related with this customer report. The product was manufactured, inspected and released in accordance with our internal procedures and no issues were observed. Our manufacturing process was reviewed and no issues were found related with the issue reported. Therefore, at this time, a root cause cannot be determined. However, an internal investigation has been initiated capa (b)(4) to investigate further and to determine if corrective actions are applicable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2011-00003 |
| MDR Report Key | 2031936 |
| Report Source | 05,06 |
| Date Received | 2011-03-28 |
| Date of Report | 2011-03-28 |
| Date of Event | 2011-03-03 |
| Date Mfgr Received | 2011-03-03 |
| Date Added to Maude | 2011-09-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478876412 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III |
| Manufacturer City | MEXICALI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALVE ONE-WAY DISPOSABLE |
| Generic Name | VALVE ONE-WAY DISPOSABLE |
| Product Code | CBP |
| Date Received | 2011-03-28 |
| Model Number | 001800 |
| Catalog Number | 001800 |
| Lot Number | Y10S0086 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-03-28 |