MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-19 for AERO-MED URINE COLLECTION KIT AMM568 manufactured by Aero-med, Ltd..
[111498654]
Patient Sequence No: 1, Text Type: N, H10
[111498655]
Employee was transferring urines, using the urine transfer cup. She went to put the red and yellow top tube onto the exposed needle portion of the cup, and the needle part got stuck inside the tube. The device has been discarded. No patient/employee harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7613839 |
| MDR Report Key | 7613839 |
| Date Received | 2018-06-19 |
| Date of Report | 2018-06-06 |
| Date of Event | 2018-05-31 |
| Report Date | 2018-06-06 |
| Date Reported to FDA | 2018-06-06 |
| Date Reported to Mfgr | 2018-06-06 |
| Date Added to Maude | 2018-06-19 |
| 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 |
| 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 | AERO-MED URINE COLLECTION KIT |
| Generic Name | BLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING) |
| Product Code | OIB |
| Date Received | 2018-06-19 |
| Catalog Number | AMM568 |
| ID Number | 8362474 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AERO-MED, LTD. |
| Manufacturer Address | 5110 WEST 74TH STREET BUILDING 97 INDIANAPOLIS IN 46268 US 46268 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-19 |