MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for SHILEY 18870 manufactured by Mmj Sa De Cv (usd).
[182769244]
Evaluation summary: one product's photos were received. The reported event was confirmed in the provided photos. Photos are provided for evaluation and it was observed the printing on the pouch describes a device (size 7. 0) and the tube inside the pouch is (size 7. 5). Capa (b)(4) was initiated to address the reported failure. The severity was assessed as 9 (hazardous - failure occurs with warning) - failure resulting in harm to user, patient, operator or environment which does not affect other system elements. Information has been added to the database and trends will continue to be monitored. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182769248]
According to the reporter, the device had wrong size was packaged. A packaged labeled as size 7. 0mm but size was 7. 5mm. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00196 |
| MDR Report Key | 9809039 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-08 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2017-10-09 |
| Date Added to Maude | 2020-03-09 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ SA DE CV (USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROLL |
| Manufacturer City | CIUDAD JUAREZ 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILEY |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 18870 |
| Catalog Number | 18870 |
| Lot Number | 17J0265JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV (USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |