MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-26 for 10 ML SINGLE DOSE MEDICATION VIAL manufactured by Unk.
[131814660]
Etomidate 20 mg/10 ml vials from zydus pharmaceuticals usa, inc. , from different areas of our hosp were discovered with the lids off and within the pocket of our pyxis machine. At first it appeared that someone had just removed the lid and then returned it to the pocket, but then this was discovered in other locations of the hosp. The lot numbers were different also. When pressure was applied to the vial top, the lid would actually remain on the vial with enough force to pick up the entire vial by the lid. This could lead to either non-sterile medication preparation. The mfr was notified and is to return my call for add'l info. Medication administered to or used by the pt: no. Pt counseling provided: unk. Relevant materials provided: image. Ismp, (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082644 |
| MDR Report Key | 8200076 |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-26 |
| Date Added to Maude | 2018-12-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| 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 | 10 ML SINGLE DOSE MEDICATION VIAL |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2018-12-26 |
| Device Availability | * |
| 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 | 2018-12-26 |