MICRO-VOLUME EXTENSION SET
Received Jan 20, 2023 · Event occurred Dec 16, 2022
Report 1416980-2023-00096 · MDR key 16218452
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: FIFTEEN (15) ACTUAL SAMPLES WERE 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. THE REPORTED CONDITION WAS NOT VERIFIED IN THE 15 SAMPLES. 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 THE UNSPECIFIED QUANTITY OF NON-DEHP MICRO-VOLUME EXTENSION SETS WERE LEAKING COMING FROM THE FILTER. THIS WAS OBSERVED DURING PATIENT INFUSION. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.