MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for MAGELLAN 8881833510 manufactured by Cardinal Health, Inc..
[184650382]
Medical assistant was following manufacturer guidelines of engaging the safety device on the needle by sliding the needle on a hard surface. The contaminated needle bent back and stuck the ma on the left thumb. The needle should have closed safely to prevent contaminated needle sticks as shown in the guidelines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871299 |
| MDR Report Key | 9871299 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-18 |
| Date of Event | 2020-02-11 |
| Report Date | 2020-02-18 |
| Date Reported to FDA | 2020-02-18 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MAGELLAN |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | FMI |
| Date Received | 2020-03-24 |
| Model Number | 8881833510 |
| Catalog Number | 8881833510 |
| Lot Number | 902844 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |