CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT CON
Received May 11, 2023 · Event occurred Oct 25, 2021
Report 3012307300-2023-05525 · MDR key 16908907
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
St PaulModel number
21-7605-24Catalog number
21-7605-24
Product problems
- Disconnection
- Disconnection
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# 617147. ONE SAMPLE WAS DECONTAMINATED INSIDE A PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGE. DURING THE VISUAL INSPECTION, THE SAMPLE RECEIVED DID NOT PRESENT ANY DAMAGE. DURING THE FUNCTIONAL TESTING NO PROBLEM WAS FOUND WITH THE ASSEMBLY OF THE CONNECTOR. THE COMPLAINT WAS NOT CONFIRMED. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS COMPLAINT NOT BEING CONFIRMED. NO ACTION WAS TAKEN DUE TO COMPLAINT NOT CONFIRMED.
Description of Event or Problem
IT WAS REPORTED THAT THE THE DISPOSABLE CASSETTE TUBING BECAME DISCONNECTED FROM THE EXTENSIONS SET. NO PATIENT INJURY WAS REPORTED.