MICRO-VOLUME EXTENSION SET
Received Jan 9, 2023 · Event occurred Dec 5, 2022
Report 1416980-2023-00011 · MDR key 16122476
Device
Generic name
Filter, Infusion Line
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
2N3350
Lot number
ASKU
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
H10: THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION USING THE NAKED EYE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ALL COMPONENTS WERE CORRECTLY PLACED AND ACCORDING TO SPECIFICATIONS. FUNCTIONAL TESTING WAS PERFORMED INCLUDING CLEAR PASSAGE AND PRESSURE TESTING AND NO BLOCKAGE WERE OBSERVED. HOWEVER, DURING PRESSURE TESTING A LEAK WAS OBSERVED FROM THE AIR VENT OF THE FILTER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DUE TO MANUFACTURING RELATED ISSUE. THIS ISSUE IS BEING FURTHER INVESTIGATED. 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 WAS LEAKING WITH AN UNSPECIFIED FLUID COMING FROM THE FILTER. THE LEAK WAS OBSERVED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.