Additional information about the incident was received regarding the patient: the patient did exhibit signs or symptoms of distress or complications related to the event.The infant was lethargic, pale, and tachypneic and the insertion site of picc was red and swollen.The infant was given antibiotics (vancomycin) and is recovering.At this time there is no follow up care required.
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A device history record (dhr) review could not be reviewed because the lot number was reported as unknown, however all dhr¿s are reviewed for accuracy prior to product release.One photograph and one catheter were received for evaluation.The photo shows that the catheter was in use by the patient because it was inserted, and a leak was observed in the tube of the catheter.A visual inspection revealed that the catheter showed signs of use (blood) and during the evaluation a leak was observed on the tube.A magnified visual inspection identified a hole near the butterfly stabilizing wing.The reported event was confirmed.Pressure leak and occlusion testing was performed to identify the possible source of the leak.A leak test is 100% executed using a calibrated equipment however, as the catheter was in the patient for several days before the leak was noticed, it is concluded that the catheter did not have the leaking condition when it was placed on the patient.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for the reported an undetermined time; therefore the most probable root cause can be considered as displacement or movement of the device during use causing the device to develop a fracture/hole.The reported complaint has not been confirmed as a manufacturing related issue.No trends or triggers have been found.Therefore, a corrective or preventive action is not deemed necessary at this time.This complaint will be used for qa tracking and trending purposes.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process and visual acceptance sampling are performed in the plant are in place to prevent non-conforming product from leaving the manufacturing operations.
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