CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT
Received Jun 9, 2022 · Event occurred May 1, 2022
Report 3012307300-2022-11311 · MDR key 14644572
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Medical Asd, Inc.Model number
21-7624-24Catalog number
21-7624-24
Product problems
- Infusion or Flow Problem
- Infusion or Flow Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER WAS PERFORMING A PRIMING DURING THE PRE-USE CHECK, HE NOTICED MEDICAL FLUID WOULD NOT PASS THROUGH THE PRODUCT. NO PATIENT WAS INVOLVED AND NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2022-11311. THE REPORT WAS SUBMITTED IN ERROR., CORRECTED DATA: CORRECTED INFORMATION PROVIDED IN H10.