MICRO-VOLUME EXTENSION SET
Received Jan 9, 2023 · Event occurred Dec 12, 2022
Report 1416980-2023-00008 · MDR key 16121396
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: AN 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 WAS OBSERVED. HOWEVER, DURING PRESSURE TESTING A LEAK WAS OBSERVED IN 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.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP MICRO-VOLUME EXTENSION SETS LEAKED AT THE FILTER. THE ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.