NRFIT CASSETTE
Received Apr 10, 2024 · Event occurred Nov 4, 2023
Report 3012307300-2024-10020 · MDR key 19079673
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-7600-24
Product problems
- Insufficient Flow or Under Infusion
- Insufficient Flow or Under Infusion
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. LOT NUMBER, EXPIRATION DATE AND H4 ARE UNKNOWN. NO PRODUCT WAS RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO LOT NUMBER WAS PROVIDED; THEREFORE, A HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. FOR ALL ENQUIRIES OR FOLLOW-UP QUESTIONS RELATED TO THE RECORD, DO NOT USE REGULATORY.RESPONSES@SMITHS-MEDICAL.COM LOCATED IN SECTIONSPLEASE DIRECT THOSE TO THE FOLLOWING: REGULATORY.RESPONSES@ICUMED.COM.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE 100 ML CASSETTE, UNDERDELIVERY OCCURRED. PER REPORTER THE CASSETTE WAS TO RUN OUT, BUT 60 ML REMAINED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.