MICRO-VOLUME EXTENSION SET
Received Dec 18, 2023 · Event occurred Sep 16, 2023
Report 1416980-2023-06588 · MDR key 18345589
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3350
Lot number
DR23B23024
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H4, H6, H10. CORRECTION: D2. H10: 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.
Additional Manufacturer Narrative
THE USER FACILITY SUBMITTED MEDWATCH MW5146011 FOR THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET LEAKED AT THE FILTER. THIS OCCURRED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.