FLOW COUPLER
Received Apr 21, 2023 · Event occurred Mar 23, 2023
Report 1416980-2023-01911 · MDR key 16787287
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
515101250010
Lot number
SP22G211708068
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
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 2.5MM FLOW COUPLER DID NOT CLOSED PROPERLY. THE EVENT WAS IDENTIFIED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.