INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
Received Apr 30, 2021 · Event occurred Apr 2, 2021
Report 1416980-2021-02533 · MDR key 11752115
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
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.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION FOR H10: BASED ON FURTHER INVESTIGATION, THE MOST PROBABLE CAUSE WAS DETERMINED TO BE RELATED TO THE END USER/METHODS EXCEEDING THE PRODUCT PRESSURE SPECIFICATIONS OF 45PSI. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED A MICRO-VOLUME EXTENSION SET LEAKED. THE EVENT WAS FURTHER REPORTED AS THE ¿FENTANYL TUBING APPEARS TO BE LEAKING AT CAP CLOSEST TO THE FENTANYL SYRINGE¿. IT WAS OBSERVED ¿FROM THE BOTTOM OF THE CAP/CONNECTION¿. THE SET WAS REPLACED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.