INTRAVASCULAR EXTENSION SETS AND ACCESSORIES
Received Jun 11, 2021
Report 1416980-2021-03590 · MDR key 11986704
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3382
Lot number
NI
Product problems
- Crack
- Fluid/Blood Leak
- Crack
- 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 (8) MICRO-VOLUME EXTENSION SETS WERE OBSERVED CRACKED WHICH SUBSEQUENTLY LEAKED. IT WAS FURTHER REPORTED ¿A COUPLE LEAKED RIGHT OUT OF THE PACKAGE¿. THE EVENTS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS ADDED TO H6. 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.