MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-31 for SMITHS MEDICAL CADD CLEO INFUSION SET 21-7220-24 manufactured by Smiths Medical Asd, Inc..
[185921528]
Information was received that while a smiths medical cadd cleo infusion set was in use, two abscesses noted on left abdominal wall at infusion site. Unspecified surgical intervention was done as a result. The incident has been reported to be resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02580 |
| MDR Report Key | 9907630 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-11-28 |
| 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 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 CLEO INFUSION SET |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-31 |
| Model Number | 21-7220-24 |
| Catalog Number | 21-7220-24 |
| Lot Number | 3677257 |
| 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 | 2020-03-31 |