Initial reporter facility name: (b)(6) hospital.Medical device lot #: unknown medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary material #: 364880 lot/batch #: unknown bd received 1 used sample for investigation.The sample was evaluated by visual examination and the rubber sleeve was confirmed to be trapped in the terumo blood collection tube closure.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.The competitor containment device (blood collection tube) used in conjunction with our btd and other acquisition products sometimes is incompatible due to the design of the closure of the tube.Other stopper designs in rare cases can trap the btd sleeve, causing it to pull off or be trapped and exposing the non-patient (np) needle.Without the sleeve in place, leakage occurs.This closure design is not as robust as the bd tubes in which the closure is a soft rubber stopper material which does not allow the sleeve to get caught or hung up.The sleeve compresses on top of the stopper allowing the np needle to pierce through the stopper material allowing blood flow.Once removing the tube from the np end, the sleeve then safely retracts back over the np needle (without any leakage) allowing the phlebotomist the opportunity to transfer another tube safely for collection.Complaints received for this device and reported condition will continue to be tracked and trended.
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