MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-05 for MEDEX STOPCOCK MX9342L manufactured by Smiths Medical Asd, Inc..
[182178839]
Information was received indicating that a smiths medical medex stopcocks broke in half causing a "dangerous drop in blood pressure until a new device was located". The reporter indicated that the patient was a vasopressor dependent. The reporter also indicated that spilt was at the contact point (gray/purple connection point between the two yellow stopcock valves). No further adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01815 |
| MDR Report Key | 9793455 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-11-25 |
| Date Added to Maude | 2020-03-05 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | PARQUE INDUSTRIAL MONTERREY |
| Manufacturer City | APODACA NL, CP 66603 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 66603 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDEX STOPCOCK |
| Generic Name | STOPCOCK, I.V. SET |
| Product Code | FMG |
| Date Received | 2020-03-05 |
| Returned To Mfg | 2020-03-04 |
| Model Number | MX9342L |
| Catalog Number | MX9342L |
| Lot Number | 3898777 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-03-05 |