COUPLER
Received Feb 3, 2023 · Event occurred Jan 12, 2023
Report 1416980-2023-00302 · MDR key 16298295
Device
Generic name
Device, Anastomotic, Microvascular
Manufacturer
Baxter Healthcare CorporationModel number
NACatalog number
511100150060
Lot number
SP22B161627780
Product problems
- Loose or Intermittent Connection
- Loose or Intermittent Connection
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PINS IN THE RING OF A 1.5MM COUPLER - 6/BX WERE LOOSE. THE ISSUE WAS IDENTIFIED BEFORE USE. 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.
Additional Manufacturer Narrative
H10: THE DEVICE WAS RECEIVED FOR EVALUATION. SIGNS OF USE (DRIED BLOOD) WERE VISIBLE ON THE COUPLER RINGS AND THE JAW ASSEMBLY. A VISUAL INSPECTION WAS PERFORMED AND THE LEFT RING IN THE JAW ASSEMBLY APPEARED TO HAVE A BENT PIN ON THE RING; HOWEVER, THE PINS DID NOT MOVE WHEN PUSHED ON USING A FORCEPS. THE REPORTED CONDITION OF LOOSE PINS WAS NOT VERIFIED, HOWEVER, A BENT PIN WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SIGNS OF USE ON THE RETURNED PRODUCT SUGGEST THAT IT WAS ATTEMPTED TO BE USED IN A SURGICAL PROCESS. THE PINS ARE DELICATE AND CAN BE DAMAGED OR BENT IN PREPARATION FOR OR DURING A SURGICAL PROCESS. 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.