H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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It was reported, "incident: during the device testing phase (prior to insertion), a leakage was observed at the catheter adapter, between the catheter junction and the foot of the midline.There were no clinical consequences for the patient, but another midline (with a different batch number) was opened.".
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