ACCESS
Received Aug 11, 2014 · Event occurred Jul 15, 2014
Report 1416980-2014-26019 · MDR key 3998815
Device
Generic name
Set, Administration, Intravascular
Manufacturer
Baxter Productos Medicos LtdaCatalog number
2C8537
Lot number
R14C12094
Product problems
- Detachment of Device or Device Component
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE TUBING OF A CONTINU-FLO SOLUTION SET BECAME DETACHED FROM THE DRIP CHAMBER. THIS OCCURRED DURING PRIMING WITH HARTMANN¿S SOLUTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Additional Manufacturer Narrative
(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.