NA
Received Jan 17, 2025 · Event occurred Dec 17, 2024
Report 1416980-2025-00094 · MDR key 21178508
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3350
Lot number
DR24D17062
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER DURING USE. THE FILTER WAS LEAKING EVEN WHEN MANUALLY FLUSHED. THE DEVICE CONTAINED FAMOTIDINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS ADDED TO H4, H6, H11. H11: 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.