It was reported that on (b)(6) 2016 at 9:30 am, a bd intima-ii¿ closed iv catheter system was placed in a patient's left hand for an infusion.On (b)(6) 2016 at 5:00 pm, the patient's parents notified a nurse that there was bleeding at the iv insertion site.When the nurse arrived the catheter was out of the patient's vein and approximately 15 mm was broken off and missing.The broken catheter was not found in the patient's room and the nurse reported the incident to the hospital at 10:00 pm.The patient then received full body x-rays and a cardiac color ultrasound.The broken catheter was not visualized within the patient.No further information has been provided about this incident.
|
Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5295044.A manufacturing review also revealed no related issues during production.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Additionally, after communication with the customer it was reported that there was no abnormality during the insertion or flushing of the catheter, there was no abnormality found before the catheter broke, and per the incident description the catheter was torn by the patient during infusion.Therefore, our quality engineer states that the complaint is not related to manufacturing.
|