MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-03-28 for SMITHS MEDICAL CADD ADMINISTRATION SET 21-7394-24 21-7081-24 manufactured by Smiths Medical Asd, Inc..
[185481169]
Information was received that with in use with a patient, a smiths medical cadd administration set was leaking liquid from the rubber of the y. Incident occurred while in use, and no patient injury resulted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02280 |
| MDR Report Key | 9894968 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-28 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-04-15 |
| Date Added to Maude | 2020-03-28 |
| 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 N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS HEALTHCARE MANUFACTURING S.A DE C.V |
| Manufacturer Street | AVE CALIDAD NO. 4 PARQUE INDUSTRIALLNTERNACIONAL |
| Manufacturer City | TIJUANA, 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL CADD ADMINISTRATION SET |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-28 |
| Model Number | 21-7394-24 |
| Catalog Number | 21-7081-24 |
| Lot Number | 3780633 |
| 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 N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |