MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-15 for STRL IV START TD 14 1ML KIT 01-98001C manufactured by Cardinal Health 200, Llc.
| Report Number | 9327493 |
| MDR Report Key | 9327493 |
| Date Received | 2019-11-15 |
| Date of Report | 2019-11-14 |
| Date of Event | 2019-11-12 |
| Report Date | 2019-11-14 |
| Date Reported to FDA | 2019-11-14 |
| Date Reported to Mfgr | 2019-11-15 |
| Date Added to Maude | 2019-11-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Brand Name | STRL IV START TD 14 1ML KIT |
| Generic Name | I.V. START KIT |
| Product Code | LRS |
| Date Received | 2019-11-15 |
| Returned To Mfg | 2019-11-14 |
| Model Number | 01-98001C |
| Catalog Number | 01-98001C |
| Lot Number | 285239 |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-15 |