MEDEX 4-WAY STOPCOCK EXTENSION SET
Received Dec 27, 2024 · Event occurred Oct 25, 2024
Report 9616567-2024-00208 · MDR key 21029175
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
MX43860
Lot number
6010011
Product problems
- Disconnection
- Disconnection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT THE ARTERIAL LINE DISCONNECTED AT 4-WAY STOPCOCK. THE EVENT OCCURRED DURING USE. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
H3: DEVICE NOT RETURNED TO MANUFACTURER. NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THERE WERE NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER.