The lot number was reviewed for complaint trend, nonconforming report and capa review.Devices met specification prior to release and no trends were noted.The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
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This follow up mdr is created to document the evaluation of the returned device.A titan pump was the only component received for evaluation.Examination and testing of the returned component revealed the inner ball was loose inside the pump bulb.Microscopic examination revealed that the spring inside the exhaust strain relief area of the pump body was turned sideways.Based on examination of the returned pump, the loose ball inside the pump bulb was noted, confirming the reported complaint.However, quality is unable to determine how this may have occurred, as no further details were provided on the events that may have led up to the reported complaint.A great amount of force would be needed to dislodge the ball and move the spring inside the pump body.No further complaints of this nature have been reported for this lot number.A review of the device history record by quality engineering confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot number.
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