CADD CASSETTE RESERVOIR
Received Dec 6, 2024 · Event occurred Oct 17, 2024
Report 3012307300-2024-14589 · MDR key 20873246
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
21-7609-24
Lot number
UNKNOWN
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D3, H6: UPDATED. H3: ONE SAMPLE AND TWO PHOTOS WERE RECEIVED. THE SAMPLE WAS VISUALLY AND FUNCTIONALLY TESTED AND THE CUSTOMER REPORTED COMPLAINT WAS ABLE TO BE CONFIRMED. A LEAK WAS DETECTED IN THE MEDICATION BAG. A DHR REVIEW WAS UNABLE TO BE COMPLETED AS NO LOT NUMBER WAS PROVIDED.
Additional Manufacturer Narrative
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 A BUBBLE ALARM HAS OCCURRED. THE CASSETTE WAS LEAKING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.