INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
Received Jun 16, 2021 · Event occurred Feb 10, 2021
Report 1416980-2021-03679 · MDR key 12009669
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3382
Lot number
ASKU
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED TWO (2) MICRO-VOLUME EXTENSION SETS LEAKED DURING PATIENT INFUSION. IT WAS FURTHER REPORTED, BOTH ¿SYRINGE TUBING WITH FILTER AT TOP OF TUBING¿ LEAKED. THE INFUSION WAS MICAFUNGIN VIA A 60 ML SYRINGE AT 50ML PER HOUR. THE EVENTS OCCURRED ON THE SAME PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H6 AND H10. H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.