MICRO-VOLUME EXTENSION SET
Received Sep 28, 2022
Report 1416980-2022-05128 · MDR key 15499524
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
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 LEAKED FROM AN UNSPECIFIED LOCATION. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
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.