COUPLER
Received Apr 25, 2023 · Event occurred Feb 15, 2023
Report 1416980-2023-01976 · MDR key 16808284
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100300060
Lot number
ASKU
Product problems
- Difficult to Open or Close
- Difficult to Open or Close
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 WITH NO OTHER PORTION OF THE PRODUCT WERE RETURNED AND THEY SHOWED SIGNS OF USE (DRIED BLOOD) CONSISTENT WITH THE PRODUCT BEING UTILIZED DURING A SURGICAL PROCESS. A VISUAL INSPECTION OF THE COUPLER RINGS DID NOT SHOW ANY DEFECT; THE RINGS AND PINS WERE ALL INTACT WITH NO DAMAGE OR BENT TIPS VISIBLE. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
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 3.0MM COUPLER WOULD NOT CLOSE. THE ISSUE WAS DISCOVERED DURING PATIENT USE. A NEW COUPLER WAS USED TO RESOLVE THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.