MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-09-05 for SINGLE LINE TRANSPAC? IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS 011-46108-38 manufactured by Icu Medical De Mexico, S. De R.l. De C.v..
| Report Number | 9617594-2019-00297 |
| MDR Report Key | 8964447 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-09-05 |
| Date of Report | 2019-08-14 |
| Date of Event | 2019-06-30 |
| Date Mfgr Received | 2019-08-14 |
| Date Added to Maude | 2019-09-05 |
| 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 | 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 | SINGLE LINE TRANSPAC? IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS |
| Generic Name | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
| Product Code | DRS |
| Date Received | 2019-09-05 |
| Returned To Mfg | 2019-08-22 |
| Catalog Number | 011-46108-38 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 COLONIA RANCHO SANTA CLARA, MA ENSENADA, B.CFA. 22790 AS 22790 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-05 |