MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-08 for ENFIT ORAL SYRINGE 818077 BP-S05NC manufactured by Neomed Inc..
[174671412]
Oral enfit medication syringe leaked from sealed side (plunger side) after filling with oral medication. Doses filled in pharmacy correctly, but by the time they found their way to the pt care unit, bedside nurse noticed volume was below indication and that there was fluid beyond the rubber seal of the plunger. Wanted to report to see if mfr has a defective lot or batch vs. Isolated syringes. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092112 |
| MDR Report Key | 9569322 |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-27 |
| Date Added to Maude | 2020-01-09 |
| 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 | 3 |
| Brand Name | ENFIT ORAL SYRINGE |
| Generic Name | ENTERAL, SYRINGES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PNR |
| Date Received | 2020-01-08 |
| Model Number | 818077 |
| Catalog Number | BP-S05NC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOMED INC. |
| Manufacturer Address | WOODSTOCK GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |