CASSETTE RESERVOIR
Received Feb 27, 2025 · Event occurred Jan 23, 2025
Report 3012307300-2025-02294 · MDR key 21480125
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
21-7600-24
Lot number
6022054
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
H6: EVALUATION CODES UPDATED. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE REPORTED COMPLAINT WAS CONFIRMED. THE PROBABLE CAUSE OF THE LEAK IS DUE TO INCONSISTENT SEALING OF THE INTERNAL BAG DURING MANUFACTURING. A DEVICE HISTORY RECORD (DHR) REVIEW REPORTED NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.
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 INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE CASSETTE WAS LEAKING WHEN IT WAS FILLED WITH MEDICINE. THERE WAS NO PATIENT INVOLVEMENT.