MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR manufactured by Icu Medical, Inc..
[184265579]
We have experienced multiple events in which a safeset, which is a device used perform blood sampling from a central line or an a-line, has broken. The break occurred within the syringe part of the system. The plunger separates from the hub inside the syringe barrel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859561 |
| MDR Report Key | 9859561 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-16 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
| Product Code | DRS |
| Date Received | 2020-03-20 |
| Lot Number | 4378738; 3780101; 4185077 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 4455 ATHERTON DR. SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |