MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-30 for 16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIRO CH3381 manufactured by Icu Medical De Mexico, S. De R.l. De C.v..
| Report Number | 9617594-2020-00093 |
| MDR Report Key | 9897807 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-30 |
| 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 | CHRISTOPHER ZANONI |
| Manufacturer Street | 600 N. FIELD DR. |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2247062300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 16" (41 CM) APPX 4.4 ML, EXT SET W/MICROCLAVE?, 0.2 MICRON FILTER, CLAVE?, SPIRO |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-30 |
| Catalog Number | CH3381 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
| Manufacturer Address | AVENIDA CUARZO NO. 250 ENSENADA, B.CFA. 22790 MX 22790 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |