MEDEX EXTENSION SETS MULTI LINE
Received Oct 26, 2023 · Event occurred Oct 18, 2022
Report 3012307300-2023-09940 · MDR key 18015035
Device
Generic name
Intravascular Administration Set
Manufacturer
Smiths Medical International, Ltd.Catalog number
MX618
Product problems
- Blocked Connection
- Blocked Connection
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS BLOCKED. REPORTED LOT NUMBER WAS 430691, BUT THIS NUMBER COULD NOT BE VERIFIED. PATIENT INVOLVEMENT IS UNKNOWN.
Additional Manufacturer Narrative
OTHER TEXT: D4: LOT NUMBER, EXPIRATION DATE, UDI SECTION, G5: 510K AND H4: MANUFACTURE DATE ARE UNKNOWN, NO INFORMATION HAS BEEN PROVIDED TO DATE. NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.