FDA Adverse Event
Malfunction
Summary report: N
MEDEX 6 PRESSURE MONITORING LINE
MDR report key: 3952192
·
Received May 13, 2014
Report
- Report Number
- 2183502-2014-00293
- Event Type
- Malfunction
- Date Received
- May 13, 2014
- Report Date
- May 12, 2014
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- FPA
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT DURING USE OF THE LISTED PRESSURE MONITORING LINE, A LEAK WAS OBSERVED WHERE THE TUBING IS BONDED TO THE LUER LOCK. REPLACEMENT OF THE MONITORING LINE WAS REQUIRED. THERE WERE NO ADVERSE EFFECTS TO PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286862 | MEDEX 6 PRESSURE MONITORING LINE | FPA - INTRAVASCULAR ADMINISTRATION SET | FPA | SMITHS MEDICAL MD, INC. | NA | 2618507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |