MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-27 for CADD CLEO INFUSION SETS SET, INSULIN, 9MM INSERTER/RETRACTOR, 24" BUCKLE A 21-7230-24 manufactured by Smiths Medical Asd,inc..
[185478931]
Cleo device was not returned. Device passed all quality testing before it was released. Unable to determine root cause. No photos and device to investigate.
Patient Sequence No: 1, Text Type: N, H10
[185478932]
?information received a smith medical cleo infusion set moved from the abdominal cavity when the consumer moved abruptly . the study drug that was being infused escaped wetting the consumers shirt and abdomen the site needed to be reinserted with new tubing and device . no adverse to consumer as the finding had action taken to preclude serious injury by changing out device .
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02278 |
| MDR Report Key | 9891698 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2018-08-21 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 LANE N |
| 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, B.C. 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD CLEO INFUSION SETS |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-27 |
| Model Number | SET, INSULIN, 9MM INSERTER/RETRACTOR, 24" BUCKLE A |
| Catalog Number | 21-7230-24 |
| Lot Number | 3675103 |
| Operator | LAY USER/PATIENT |
| 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 | 2020-03-27 |