MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for FILTER, INFUSION LINE manufactured by Smiths Medical Asd, Inc..
[176979922]
Filter leaking at one of the holes on the filter (it is held together with two site, leaking at one).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9646608 |
| MDR Report Key | 9646608 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-23 |
| Date of Event | 2020-01-15 |
| Report Date | 2020-01-23 |
| Date Reported to FDA | 2020-01-23 |
| Date Reported to Mfgr | 2020-01-30 |
| Date Added to Maude | 2020-01-30 |
| 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 |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2020-01-30 |
| Lot Number | 3899558 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |