GEM FLOW COUPLER
Received Jun 15, 2024
Report 1416980-2024-02926 · MDR key 19544379
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Synovis Micro Companies Alliance, IncModel number
GEM2753FCCatalog number
515101250010
Lot number
SP23L04-1985433
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A 2.5MM FLOW COUPLER WAS BROKEN (NOT FURTHER SPECIFIED). THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, D9, H3, H4, H6, H11. H11: THE ACTUAL FLOW COUPLER DEVICE WAS NOT AVAILABLE; HOWEVER, THE PACKAGING COMPONENTS WERE RETURNED (CARTON, INSTRUCTIONS FOR USE, IMPLANT RECORD, AND OUTER TRAY WITH LID PULLED BACK). VISUAL INSPECTION OF THE PACKAGING COMPONENTS DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE REPORTED CONDITION WAS NOT VERIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.