The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 2021-09-13.H6: investigation summary.Customer returned a single syringe in a polybag labeled for 0.5ml, 31 gauge, 8mm syringes from lot 1011586.The syringe inside was also found to have had its thumbpress break off from the base of the plunger rod, with the thumbpress itself slightly warped.The break is uneven and happened at an angle.Lastly, the plunger cap was noted to be damaged and bent in several spots, which may have contributed to it easily separating if not falling off from the body of the syringe.A review of the device history record was completed for batch# 1011586.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the samples received, bd was able to confirm the customer¿s indicated failure of the plunger cap separating from the syringe.
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