NRFIT CONNECTOR, ADAPTER, FILLING, MALE/FEMALE LUER, 50/BX
Received Sep 5, 2024 · Event occurred Aug 7, 2024
Report 3012307300-2024-08644 · MDR key 20152206
Device
Generic name
Administrations Sets With Neuraxial Connectors
Manufacturer
Smiths Medical Asd, Inc.Catalog number
21-7664-24
Lot number
6010324
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
H3: DEVICE NOT RECEIVED BY MANUFACTURER. 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 ADAPTER OF THE CADD CASSETTE IS LEAKING AT THE CONNECTION ON THE MIDDLE. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
H6: EVALUATION CODES UPDATED. DEVICE EVALUATION: ONE COMPONENT WAS RETURNED FOR INVESTIGATION. THE COMPONENT WAS AIR LEAK TESTED PER ICU MEDICAL SPECIFICATIONS AND FAILED. THE COMPLAINT CAN BE CONFIRMED. A QUALITY ALERT HAS BEEN POSTED COVERING PROPER SOLVENT APPLICATION FOR ASSOCIATE REVIEW. IN THE PAST TWO YEARS, NO OTHER COMPLAINTS HAVE BEEN FILED FOR THE DESCRIBED DEFECT. ICU MEDICAL CONTINUES TO TRACK AND TREND COMPLAINTS DATA AND ESCALATE AS NEEDED. NO NON-CONFORMANCE REPORTS WERE ISSUED AGAINST THIS LOT DURING THE MANUFACTURING.