MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for LIPID FILTER manufactured by Unk.
[129300993]
We had a chipped lipid filter make it the newborn icu. When the rn was priming the line, lipids leaked at the connection port. When examining the line, very small chip was identified that it was the culprit. Lipids were stopped that night so didn't reach the pt's picc line. Pictures of products available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081786 |
| MDR Report Key | 8125108 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-15 |
| Date Added to Maude | 2018-12-03 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHARMACIST |
| 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 | 0 |
| Brand Name | LIPID FILTER |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2018-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-30 |