(b)(4).The pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.Results: one used sample was returned for evaluation.A visual inspection of the sample revealed that it was without the square cover.The safety mechanism (v-clip) was observed to be activated.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6111025.A manufacturing review revealed no abnormalities with preventative maintenance, calibration, or equipment.Conclusion: an absolute root cause for this incident cannot be determined.(b)(4).
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It was reported that after placement of a 20 g x.32 mm bd venflon pro safety peripheral safety iv catheter with injection valve, a piece of the safety mechanism detached from the device.There was no report of injury, clinical consequences, or medical intervention.
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