The lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device has been returned for evaluation; the evaluation identified circumferential rupture and break along with leak from the split.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.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.
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