The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-nov-2022.H6: investigation summary : our quality engineer inspected the sample submitted for evaluation.Bd received one 22gx1.00in insyte autoguard device from lot number 2146301.A gross visual inspection shows a catheter with media indicating that it has been used.Further microscopic inspection shows a catheter with a damage that has the v-shape form near the tip.The observed damage is identical to that created when the needle pierces the catheter wall near the tip giving a spear through, thus confirming the reported issue.The catheter and needle tip were inspected and found acceptable per specification.Although the reported issue was confirmed for a spear through, it could not be determined if the damage resulted from the manufacturing of the device or from the user environment.During manufacturing, this may occur due to the alignment of the set together station, bent tubing, or air blow inconsistency.As the returned unit has been removed from the package and handled, it is also possible that the defect originated due to improper use either during tip adhesion break or during the venipuncture attempt in the clinician environment.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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