COUPLER
Received May 10, 2023 · Event occurred Apr 10, 2023
Report 1416980-2023-02279 · MDR key 16907034
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100250060
Lot number
SP22E121669547
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H10: THE DEVICE WAS RECEIVED FOR EVALUATION. THE COUPLER RINGS WERE RETURNED, FREE FLOATING WITH THE JAW ASSEMBLY INSIDE THE INNER TRAY. SIGNS OF USE (DRIED BLOOD/TISSUE) WERE VISIBLE ON THE RETURNED PRODUCT WHICH IS CONSISTENT WITH THE ALLEGED EVENT TAKING PLACE DURING USE. A VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE VISUAL INVESTIGATION DID NOT SHOW ANY BENT PINS VISIBLE ON EITHER OF THE 2.5MM COUPLER RINGS. THE REPORTED CONDITION WAS NOT VERIFIED. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE PINS OF A 2.5MM COUPLER WERE BENT. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.