MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-13 for SHILEY 8PERC manufactured by Mmj Sa De Cv (usd).
[179402933]
One sample of device was received for evaluation. The reported condition was confirmed. A visual inspection was performed and it was observed the tube presents signs of being used. The severity was assessed as 8 (loss of primary function). Device or item inoperable. Replacement or repair is required to obtain desired performance. No corrective actions required since the returned sample comply with the current product specifications and process controls established at the manufacturing site. Replacement or repair is required to obtain desired performance. 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
[179402934]
According to the reporter, the device had broken white piece on top of the flange. It was stated that the separation of white piece noticed during changing of inner cannula. The patient had a replacement of the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00118 |
| MDR Report Key | 9708985 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2018-10-24 |
| Date Added to Maude | 2020-02-13 |
| 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, TRACHEOSTOMY (W/WO CONNECTOR) |
| Product Code | BTO |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 8PERC |
| Catalog Number | 8PERC |
| Lot Number | 18J0641JZX |
| 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 | 1. Required No Informationntervention | 2020-02-13 |