MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for SHILEY 18875 manufactured by Covidien Lp.
[184467681]
After intubating a patient, it was discovered that the cuff was malfunctioning and leaking air, requiring the tube to be replaced. The tube cuff was checked prior to insertion. After intubation, patient continued to have increased respiratory distress, high respiratory rate, and had events of desaturation despite being on a ventilator. The patient had to be sedated, paralyzed and re-intubated to solve this problem, during which the patient required vasopressors due to the required levels of sedation. This also required the patient to have a central line inserted. This was another faulty cuff. We have saved it and will be sending it down to materials management with materials. The central line was a different matter, just happened at the same time. We have had issues with these et tubes for some time now and when we find a faulty one we send it down to materials so they can carry the issue from there.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9864930 |
| MDR Report Key | 9864930 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-07 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2020-03-23 |
| Model Number | 18875 |
| Catalog Number | 18875 |
| Lot Number | 19G1034JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-23 |