MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-31 for MEDEX NON_DEHP EXT SET 1.2 MX448HFB manufactured by Smiths Medical Asd, Inc..
| Report Number | 9259708 |
| MDR Report Key | 9259708 |
| Date Received | 2019-10-31 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-02-27 |
| Report Date | 2019-10-15 |
| Date Reported to FDA | 2019-10-15 |
| Date Reported to Mfgr | 2019-10-31 |
| Date Added to Maude | 2019-10-31 |
| 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 |
| Brand Name | MEDEX NON_DEHP EXT SET 1.2 |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2019-10-31 |
| Returned To Mfg | 2019-03-11 |
| Model Number | MX448HFB |
| Lot Number | (17)250501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6250 SHIER RINGS RD. DUBLIN OH 43016 US 43016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-31 |