MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for EVIDENT TAMPER CAP 7321 manufactured by Baxter Healthcare Corporation.
[143079314]
Rn alerted pt safety officer of potential choking hazard of tamper evident cap for baxter oral dispenser. When cap is opened indicating it has been opened or tampered with, the ring flows loosely along the syringe shaft and can fall off into an infant or child's mouth and result in choking. There was no adverse event but there is potential choking hazard of the ring. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086087 |
| MDR Report Key | 8544888 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-21 |
| Date Added to Maude | 2019-04-24 |
| 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 | EVIDENT TAMPER CAP |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2019-04-23 |
| Model Number | 7321 |
| Catalog Number | 7321 |
| Lot Number | 23227 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-23 |