H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.The result of the investigation is inconclusive for the reported connection problem.The root cause for the reported connection problem could not be determined based upon the available information received from the field communications.Labeling review: instructions for use for the halo one thin-walled guiding sheath was reviewed and the following sections are applicable: precautions: 7.Careful attention must be paid to the maintenance of tight valve connections for duration of procedure to avoid blood leakage or the introduction of air into the system.Take remedial action if any excessive blood leakage is observed.8.Insert dilator into the center of the sheath valve.Forced insertion of the dilator which misses the center of the valve may cause damage and result in blood leakage.9.Advance or withdraw the sheath slowly.If resistance is met do not advance or withdraw until the cause of resistance is determined.10.When inserting, manipulating or withdrawing a device through the introducer always maintain the introducer position.11.Remove the dilator from the sheath slowly to avoid incomplete closing of the valve resulting in blood leakage.Potential adverse effects: ¿ hemorrhage, including bleeding at the puncture site h10: d4 (expiry date: 07/2022), g3, h6 (method) 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.
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