FDA Adverse Event
Malfunction
Summary report: N
WALKMED INFUSION 36" TUBE SET WITH PRESSURE CELL
MDR report key: 6182979
·
Received December 16, 2016
Report
- Report Number
- 1723533-2016-00180
- Event Type
- Malfunction
- Date Received
- December 16, 2016
- Date of Event
- February 2, 2015
- Report Date
- May 27, 2016
- Manufacturer
- WALKMED INFUSION, LLC.
- Product Code
- FPA
- PMA / PMN Number
- K873961
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ADMINSTRATION SET IN QUESTION WAS RETURNED TO WALKMED INFUSION FOR EVALUATION. A VISUAL INSPECTION REVEALED THE DEVICE HAD COMPLETED SPLIT AT THE FILTER CONNECTION. THERE WERE NO OBSERVED DEVIATIONS WHILE REVIEWING THE MANUFACTURING RECORDS FOR THIS DEVICE'S LOT. WALKMED INFUSION WAS UNABLE TO CONFIRM THE DEFECT WAS A RESULT OF THE MANUFACTURING PROCESS AND NO ROOT CAUSE WAS IDENTIFIED FOR THE LEAK. THIS APPEARS TO BE AN ISOLATED INCIDENT.
Description of Event or Problem · 1
A LEAK WAS OBSERVED WHILE USING A WALKMED INFUSION ADMINISTRATION SET. THERE WERE NO REPORTS OF ANY INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832546 | WALKMED INFUSION 36" TUBE SET WITH PRESSURE CELL | INTRAVASCULAR ADMINISTRATION SET | FPA | WALKMED INFUSION, LLC. | 21114507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |