MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for HYDROMORPHONE HCI CARPUJECT INJECTOR manufactured by Hospira, Inc..
[184665791]
Carpuject broke off during injection. Diagnosis for use: pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093864 |
| MDR Report Key | 9865094 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-03-07 |
| Date Added to Maude | 2020-03-23 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROMORPHONE HCI CARPUJECT INJECTOR |
| Generic Name | ADAPTOR, HOLDER, SYRINGE |
| Product Code | IQG |
| Date Received | 2020-03-20 |
| Lot Number | 10760LL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA, INC. |
| Brand Name | 1MG/ML ML MILLILITRE(S) |
| Product Code | --- |
| Date Received | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |