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 2017-05-16 for STJ408310 manufactured by Sterilmed, Inc..
[75325170]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report unable to be reviewed as no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
[75325171]
It was reported that the valve cap came off during the procedure. Per photo evidence, no parts fell inside patient as it is still attached to the device. No harm or consequences to the patient were reported.
Patient Sequence No: 1, Text Type: D, B5
[87058139]
The customer returned the device for evaluation to the manufacturer. The device was examined under magnification and no trace of adhesive was found on either the cap or the introducer hub. Based on this evidence, it appears that the cap was not properly adhered to the introducer hub.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2017-00011 |
| MDR Report Key | 6570934 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-16 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-04-18 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-05-16 |
| 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 | 2017-05-16 |
| Returned To Mfg | 2017-06-14 |
| Model Number | STJ408310 |
| Catalog Number | STJ408310 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-05-16 |