MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for CADD CASSETTE 100 ML W/ FLOWSTOP manufactured by Smiths Medical Asd, Inc..
[185930045]
Pt reports when she removed cap from pre-filled cassette, the medication sprayed out everywhere, as she began priming the extension set. She said the line felt like i had a lot of pressure in it, like a fire hose does. No further details provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093979 |
| MDR Report Key | 9903097 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-09 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD CASSETTE 100 ML W/ FLOWSTOP |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |