MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-30 for CADD ADMINISTRATION SET 21-7394-24 manufactured by Smiths Medical Asd, Inc..
[185670257]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[185670258]
Information was received indicating that during use, a smiths medical cadd administration set was leaking chemo drug (etoposide in 500ml) from administration set filter. Subsequently, patient was able to receive rest of their infusion. No patient consequences were reported. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02413 |
| MDR Report Key | 9900502 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-01-16 |
| Date Added to Maude | 2020-03-30 |
| 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 HEALTHCARE MANUFACTURING S.A. DE C.V. |
| Manufacturer Street | AVE CALIDAD NO. 4 PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA, |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD ADMINISTRATION SET |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-30 |
| Model Number | 21-7394-24 |
| Catalog Number | 21-7394-24 |
| Lot Number | 3739061 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-30 |