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 2020-03-10 for SHILEY 86112 manufactured by Mmj Sa De Cv(usd).
[182912845]
One sample was received for evaluation. Service personnel inspected and verified the reported issue, found cuff presents a small cut. An inflation/deflation test was performed 25 cc of air was applied to the cuff using a syringe and it was observed after seconds the cuff deflated. The device failed to meet specification as it was received or made available for evaluation. The investigation of observed condition isolated the failure to the damaged cuff. 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
[182912846]
According to the reporter, it was noted after intubation with a glide scope that there was a significant air leak while bagging and poor volumes on vent were confirmed. The patient was re-intubated with new endotracheal tube(ett) without any complications. It was noticed that the first ett cuff would deflate with very little pressure applied to cuff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2020-00201 |
| MDR Report Key | 9814429 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-05-02 |
| Date Added to Maude | 2020-03-10 |
| 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 DESARROL |
| 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 | 2020-03-10 |
| Returned To Mfg | 2020-02-17 |
| Model Number | 86112 |
| Catalog Number | 86112 |
| Lot Number | 19E0042JZX |
| 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 DESARROL CIUDAD JUAREZ 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |