MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-20 for SMITHS MEDICAL CADD EXTENSION SET manufactured by Smiths Medical Asd, Inc..
[186313654]
Mw5092701.
Patient Sequence No: 1, Text Type: N, H10
[186313655]
Information was received that a smiths medical cadd extension set gets twisted and disconnects. It takes several attempts to connect correctly. Patient did switch to a different tubing set to continue infusion. The incident did not occur while in use with a patient, and was reported to be resolved. Remodulin was being infused at 2 mg/ ml. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02071 |
| MDR Report Key | 9862033 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 MEDICAL ASD, INC. |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL CADD EXTENSION SET |
| Generic Name | INTRAVENOUS EXTENSION TUBING SET |
| Product Code | OJA |
| Date Received | 2020-03-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |