MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-25 for TUBE TRACHEOSTOMY AND TUBE CUFF manufactured by Smiths Medical Asd,inc..
[184995768]
No product to be returned. The product was packaged (b)(6) 2019 on alloyd 2. Dhr's review found no discrepancies or anomalies relevant to the complaint. In-process, product was inspected for leakage and no non-conformities were noted. Incoming records review for cuff component cp370 (lot # 3859259) found no issues relevant to the complaint.
Patient Sequence No: 1, Text Type: N, H10
[184995769]
Information received a smith medical tracheostomy reports cuff is failing and damaged. The reporter stated third tach to have same issue. Unknown what brand. The event reported this occurred immediately upon use. No reported adverse events to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02238 |
| MDR Report Key | 9881210 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD,INC |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-25 |
| Model Number | TRACHEOSTOMY |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD,INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |