MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for MICRON FILTER manufactured by Smiths Medical Asd, Inc..
[183520321]
Two rn's & 1:1 sitter at bedside during the time of this event. Patient was being supervised very closely at this time while changing diaper and bedding. Patient was sitting up and did not touch line at this time, was very cooperative. Line became disconnected on its own and was found lying on the bed after completion of cleaning patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9834778 |
| MDR Report Key | 9834778 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-22 |
| Report Date | 2020-03-05 |
| Date Reported to FDA | 2020-03-05 |
| Date Reported to Mfgr | 2020-03-16 |
| Date Added to Maude | 2020-03-16 |
| 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 | MICRON FILTER |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2020-03-16 |
| 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 | 2020-03-16 |