COUPLER
Received Dec 28, 2023 · Event occurred Nov 21, 2023
Report 1416980-2023-06791 · MDR key 18409357
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100100060
Lot number
SP20L151495347
Product problems
- Incomplete or Inadequate Connection
- Incomplete or Inadequate Connection
Patient
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 1.0MM COUPLER WAS UNABLE TO BE FULLY ATTACHED. THE EVENT WAS IDENTIFIED DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
H10: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS RETURNED WITH ONLY COUPLER RINGS PRESENT AND PACKAGING COMPONENTS. THE RETURNED COMPONENTS SHOWED SIGNS OF USE - RINGS DISLODGED AND DRIED BLOOD. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. DUE TO THE LACK OF FULL COUPLER JAW ASSEMBLY BEING RETURNED, THE REPORTED ISSUE CANNOT BE DEFINITIVELY REFUTED. 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.