MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-04 for EXTENSION SET SF3258-15H manufactured by Icumedical.
[104563050]
Nurse infusing ivig and spiked the bottle with secondary tubing. When nurse vented the tubing, medication began to leak out of the vent hole.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076323 |
| MDR Report Key | 7398797 |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-28 |
| Date Added to Maude | 2018-04-05 |
| 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 |
| 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 | EXTENSION SET |
| Generic Name | TUBING, FLUID DELIVERY |
| Product Code | FPK |
| Date Received | 2018-04-04 |
| Model Number | SF3258-15H |
| Lot Number | 3610742 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICUMEDICAL |
| Manufacturer Address | SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-04 |