MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2012-07-25 for MASK VENTURI DUAL DIAL ADULT 50/CS 001255-A manufactured by Carefusion.
[2835684]
The directions for use were missing in the package and nurse was unfamiliar with needing to connect the two pieces in order for the mask to function properly and assembled the venti mask incorrectly. The product was being used on a patient in the icu at the time of the reported incident. The rapid response team was required to stabilize the patient as the patient was desaturating. The issue was resolved and patient outcome was fine.
Patient Sequence No: 1, Text Type: D, B5
[9983574]
(b)(4). Results of evaluation: the sample received was evaluated. The complaint was confirmed. At the time this lot number was manufactured, carefusion was including one dfu per case of product, and not one per individual unit. Following this complaint, the process was revised and individual ifus were added to each product package. Complaint identified for submission as an mdr following a retrospective review of mexicali self-manufactured complaints under capa (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2012-00161 |
| MDR Report Key | 2668926 |
| Report Source | 00 |
| Date Received | 2012-07-25 |
| Date of Report | 2010-06-09 |
| Date of Event | 2010-06-09 |
| Date Mfgr Received | 2010-06-09 |
| Date Added to Maude | 2012-07-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| 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 | MASK VENTURI DUAL DIAL ADULT 50/CS |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATION, VENTURI |
| Product Code | BYF |
| Date Received | 2012-07-25 |
| Returned To Mfg | 2010-06-21 |
| Model Number | 001255-A |
| Lot Number | Y10B2358 |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-25 |