MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-11-07 for MISTY OX MULTI-FIT 441H manufactured by Carefusion/bd.
[59288980]
Carefusion has confirmed the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding situation reported with the device. Customer advocacy is still waiting for additional information regarding the reported issue. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[59288981]
Customer reported that the respiratory therapist (rt) went to see the patient on 96% high flow nasal cannula, and the patient was desaturating on rt's arrival into the room. Rn reported that the product fell off wall from white collar. Rt went to assess and there was no black o ring, white collar still attached to flow meter and yellow collar falling off. It was confirmed that there was patient involvement with no permanent harm.
Patient Sequence No: 1, Text Type: D, B5
[65093984]
Follow up submission: no physical sample was provided for evaluation. However, a photograph was provided and the black ring with part number (b)(4) was missing from the white collar (wing nut p/n (b)(4)). The root cause of the reported issue is related to the assembly personnel at not assembling the components correctly. To correct this issue, manufacturing personnel have been retrained on the assembly procedure to avoid these types of issues. A 2-year retrospective complaint review was performed and no adverse trend was identified relating to this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2016-00257 |
| MDR Report Key | 6082264 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-11-07 |
| Date of Report | 2017-01-16 |
| Date of Event | 2016-09-14 |
| Date Mfgr Received | 2017-01-04 |
| Date Added to Maude | 2016-11-07 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | CAREFUSION/BD |
| Manufacturer Street | CERRADA V 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 | MISTY OX MULTI-FIT |
| Generic Name | NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) |
| Product Code | CCQ |
| Date Received | 2016-11-07 |
| Catalog Number | 441H |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION/BD |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-07 |