PERIFIX®
Received Dec 18, 2024 · Event occurred Nov 21, 2024
Report 9610825-2024-00914 · MDR key 20967957
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
B Braun Melsungen AgModel number
4514017CLot number
23H25A8701
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE CUSTOMER: "DURING THE EXIT OF THE EPIDURAL CATHETER (PERIFIX ONE 401 FILTER SET) FROM THE PATIENT'S BODY, THE TIP OF THE CATHETER WAS CUT OFF FOR NO PARTICULAR REASON."
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.