MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-31 for CADD 100 ML MEDICATION CASSETTE RESERVOIR 21-7302-24 manufactured by Smiths Medical Asd, Inc..
[185906444]
Information was received indicating that a smiths medical cassette had a fold in the bladder of the cassette which would cause multiple air bubbles that could not be dispelled during the reconstitution process and that there were multiple air bubbles that despite manipulation with a syringe, the air bubbles were caught in the edge of the bladder. There were no adverse events reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02505 |
| MDR Report Key | 9908432 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-31 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD 100 ML MEDICATION CASSETTE RESERVOIR |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-31 |
| Model Number | 21-7302-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |