MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-07 for BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT 100/860/070CZ manufactured by Smiths Medical Asd, Inc..
[135708485]
Information was received that a smiths medical blue line ultra suctionaid tracheostomy tube kit had a crack on the blue connect tip of the suction port. This was noted while connecting the luer lock 10ml syringe, resulting in excess moisture on the site, causing discomfort to the patient. No patient injury occurred and no medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-00637 |
| MDR Report Key | 8318009 |
| Date Received | 2019-02-07 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-01-08 |
| Date Mfgr Received | 2019-03-11 |
| Date Added to Maude | 2019-02-07 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL CZECH REPUBLIC A.S. |
| Manufacturer Street | OLOMOUCK? 306 |
| Manufacturer City | HRANICE, MESTO 753 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 753 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT |
| Generic Name | TRACHEOBRONCHIAL SUCTION CATHETER KIT |
| Product Code | OFR |
| Date Received | 2019-02-07 |
| Returned To Mfg | 2019-03-22 |
| Catalog Number | 100/860/070CZ |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-02-07 |