(b)(4).The physical samples are in the sealed packaging blister and visual inspection was performed finding no damages or foreign matter.The clarity is also good.One photo was provided and it shows of the samples received.As no defects were observed, a cause for this defect could not be provided based on the investigation and with the sample/ photo sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.Probable root cause is unknown.It is recommended that the bd china medical function contacts the hospital to have better understanding of the patient symptoms before, during and after use of the product.
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It was reported that a syringe 10ml saline fill china sp had incorrect barrel label placement resulting in serious injury during use.The following was reported by the initial reporter: "the patient undergoes picc maintenance in the outpatient clinic.During the maintenance process, a bolus of 10ml flush was injected.After the bolus, the patient fainted immediately.The patient is currently transferred to the emergency department.The specific situation requires follow-up.The patient used catheter is a bd three-way valve picc.It have communicated with the head nurse of the emergency department.After treatment by the nursing department, the performance of the patient's family is relatively stable.The flush used by the patient was kept by the hospital.Retrieve 5 products of the same batch number.The rest has been temporarily not used by the hospital.5 samples were retrieved at random.It was found that label was stuck aslant with glue on the surface.
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