MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-22 for STJ408310 manufactured by Sterilmed, Inc..
[75619271]
No device will be returned, it was reported to be accidentally discarded by the facility. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[75619272]
It was reported that the hub assembly came apart while inside patient. There was no harm or consequence to the patient. No device will be returned, it was accidentally discarded by the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2017-00012 |
| MDR Report Key | 6581264 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-22 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | AGILIS SHEATH |
| Product Code | PNE |
| Date Received | 2017-05-22 |
| Model Number | STJ408310 |
| Catalog Number | STJ408310 |
| Lot Number | 1968801 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-22 |