MalfunctionKSS
FENWAL SAMPLING SITE COUPLER
Received Dec 14, 2021 · Event occurred Dec 9, 2021
Report MW5106054 · MDR key 13011596
Device
Generic name
Supplies, Blood-bank
Manufacturer
Fresenius Kabi / Fenwal International, Inc.Model number
4C2405FLot number
GD900969
Product problems
- Material Separation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
RUBBER TIP FOR ENTRANCE INTO SAMPLING SITE COUPLE FELL OFF WHEN NEEDLE WAS INJECTED INTO COUPLER, CREATING AN OPEN COUPLER WITH NO CLOSURE. FDA SAFETY REPORT ID # (B)(4).