FDA Adverse Event
Injury
Summary report: N
MEDEX LARGE BORE - HI-FLO STOPCOCK
MDR report key: 8550706
·
Received April 25, 2019
Report
- Report Number
- 3012307300-2019-02117
- Event Type
- Injury
- Date Received
- April 25, 2019
- Date of Event
- October 27, 2018
- Report Date
- April 25, 2019
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FMG
- UDI-DI
- 10351688504173
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX LARGE BORE - HI-FLO STOPCOCK WAS IN USE WITH PATIENT FOR AN INFUSION OF LEVOPHED. THE REPORTER STATED DEVICE BECAME DISCONNECTED FROM THE CENTRAL LINE, CAUSING A SUDDEN DROP IN THE PATIENT'S BLOOD PRESSURE. SUBSEQUENTLY, PHENYLEPHRINE WAS ADMINISTERED WITH NO EFFECT. ONCE THE HOSPITAL STAFF WERE ABLE TO RECONNECT THE LINE, THE PATIENT'S BLOOD PRESSURE INCREASED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346222 | MEDEX LARGE BORE - HI-FLO STOPCOCK | STOPCOCK, I.V. SET | FMG | SMITHS MEDICAL ASD, INC. | MX9341L | 3623939 | 10351688504173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |