MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for Q2 95906 manufactured by Quest Medical, Inc..
[111213789]
Patient Sequence No: 1, Text Type: N, H10
[111213790]
Nurse was flushing the line and there was a "sudden resistance" at which time the cap came off and fluid sprayed out of the pivo connection port into her eye, face and arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7605349 |
| MDR Report Key | 7605349 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-05-30 |
| Report Date | 2018-06-04 |
| Date Reported to FDA | 2018-06-04 |
| Date Reported to Mfgr | 2018-06-04 |
| Date Added to Maude | 2018-06-15 |
| 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 |
| 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 | Q2 |
| Generic Name | IV EXTENSION SET |
| Product Code | FPK |
| Date Received | 2018-06-15 |
| Model Number | NA |
| Catalog Number | 95906 |
| Lot Number | 054872 |
| ID Number | NA |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-15 |