Medical device expiration date: unknown.Device manufacture date: unknown.Results: investigation summary: actual sample was received and decontaminated by(b)(6).No retention samples were evaluated.The customer returned a sample of 22g defect, close to the catheter adapter of the catheter has broken and the section of the catheter is smooth, the residual of broken catheter was about 2mm.A review of the device history record could not be performed as a lot number was not provided for this incident.According to the original information in the complaint ¿puncture on (b)(6) the infusion ended on (b)(6) and found that there were drums and exudate, and then the catheter was broken when catheter was removed.¿ the information given shows: the sample was transfused for six days and the transfusion for six days were normal.During the six-day infusion, there is no breakage.To sum up, the product has not abnormality in the process of puncture and infusion.In summary, bd (b)(4) cannot confirm no defect related with the factory.The defect sample returned by the customer, revealed the catheter section smooth.After six days of infusion, the infusion was not abnormal.During the infusion, the sample was damaged or broke and the cause of the defect was not confirmed.Conclusion : although the reported defect was confirmed by visual inspection, an absolute root cause for this incident cannot be determined.No capa is required.
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It was reported that following the sixth infusion, while the nurse was removing a bd intima ii¿ closed iv catheter system, the catheter was found to broken.An ultrasound and operation was carried out on the female (b)(6) patient to remove the broken catheter.It was reported that the patient was initially admitted for a cerebral infarction.There was no additional medical information reported.
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