MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-29 for SMITHS MEDICAL PORTEX LARYNGEAL TUBES 32-01-004J manufactured by Smiths Medical Asd, Inc..
[128855837]
Information was received that a smiths medical laryngeal-tube had the slip-joint connector break following the intubation of a patient. Immediately following, it was replaced with another one.
Patient Sequence No: 1, Text Type: D, B5
[134636671]
Corrected information: initial report was filed inadvertently. This device is not approved for distribution in the u. S. And is not same or similar to a product commercially available in the u. S. The event reported under mdr 3012307300-2018-08580 was determined to be not reportable and no further reports will be filed using this file number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2018-08580 |
| MDR Report Key | 8117821 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-29 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-10-27 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-29 |
| 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 |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL PORTEX LARYNGEAL TUBES |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-11-29 |
| Returned To Mfg | 2018-11-21 |
| Catalog Number | 32-01-004J |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-11-29 |