MalfunctionLZF
JOEY 1000ML PUMP SET
Received Dec 22, 2020 · Event occurred Dec 16, 2020
Report 1282497-2020-09807 · MDR key 11057270
Device
Product problems
- Infusion or Flow Problem
- Infusion or Flow Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.
Description of Event or Problem
THE DISTRIBUTOR REPORTED A HOME PATIENT EXPERIENCED KINKS IN THE TUBING AND AIR POCKETS PREVENTING THE FEED FROM DELIVERING. THERE WAS NO HARM TO THE PATIENT.