As reported, when flushing a 5f 100cm 135-degree angled tempo diagnostic catheter with saline, the proximal end of the white was found leaking and the device could not be used.As a result, an unknown catheter was used as a replacement.The unknown catheter was able to be flushed without evidence of leakage.There was no reported injury to the patient and the device will be returned for evaluation.The hospital reported this as an adverse event to the china nmpa directly.
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As reported, when flushing a 5f 100cm 135-degree angled tempo diagnostic catheter with saline, the proximal end of the white was found leaking and the device could not be used.As a result, an unknown catheter was used as a replacement.The unknown catheter was able to be flushed without evidence of leakage.There was no reported injury to the patient and the device will be returned for evaluation.The device was not returned for evaluation.A product history record (phr) review of lot 18105540 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub ¿ catheters-cracked¿ could not be confirmed or further clarified without the return of the device for evaluation.Procedural and/or handling factors such as device damage upon removal from the packaging or loading a wire.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use , flush all devices with sterile heparinized saline or similar isotonic solution.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.H3 other text : device not returned.
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