MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2020-03-23 for TUBE TRACHEOSTOMY AND TUBE CUFF TRACH DIC CUF FEN 6.0MM + 1/EA 513060 manufactured by Smiths Medical Asd,inc..
[184632140]
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
[184632141]
Information received a smith medical tracheostomy
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02199 |
| MDR Report Key | 9869271 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-09-16 |
| Date Added to Maude | 2020-03-23 |
| 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 | 10 BOWMAN DRIVE, |
| Manufacturer City | KEENE,, NH |
| 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 | 2020-03-23 |
| Model Number | TRACH DIC CUF FEN 6.0MM + 1/EA |
| Catalog Number | 513060 |
| Lot Number | 3865716 |
| 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 | 1. Required No Informationntervention | 2020-03-23 |