CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT
Received Aug 2, 2022 · Event occurred Jul 1, 2022
Report 3012307300-2022-14453 · MDR key 15154409
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Medical Asd, Inc.Model number
21-7609-24Catalog number
21-7609-24
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHEN FILLING UP MEDICAL FLUID INTO THE PRODUCT USING A SYRINGE IN THE PRE-USE CHECK, THE CUSTOMER NOTICED THE SYRINGE TIP BROKE OFF AND GOT CAUGHT IN THE CONNECTOR. NO PATIENT INJURY WAS REPORTED.
Additional Manufacturer Narrative
A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
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: 3012307300-2022-14453. THE REPORT WAS SUBMITTED IN ERROR., CORRECTED DATA: CORRECTED INFORMATION PROVIDED IN H10.