It was reported that bd needle eclipse 25x5/8 leaked.The following information was provided by the initial reporter: it was reported by the customer that they noticed the medication was leaking out.Verbatim: rcc received a complaint via email.Email(s) attached.Quality issue product performance (leaking).When the nurses start injecting medications, they noticed the medication was leaking out.No patient injury reported.Nov 30 ¿ towards the completion of a subcutaneous injection of chemotherapy (bortezomib), i noted a single small drop of the drug that leaked onto the patient's skin as i was slowly injecting the drug.I immediately stopped pushing on the syringe plunger to prevent loss of any more drug / fluid.Dec 5 ¿ atropine leaked out of the syringe.The needle would not connect properly with the syringe.Dec 12 ¿ one drop of bortezomib came out of connection of the needle and equashield, unable to estimate how much in volume.Dec 18 ¿ vitamin b12 injection being administered to pt.Lot # 2011005 25g x 5/8 needle adapter (bd eclipse needle) was used during administration.Upon administration writer noticed minimal leakage at connection site between needle adaptor and syringe.Administration stopped.Feb 2 - rn went to connect 25g needle to 10mls syringe of daratumumab and needle would not secure properly on the syringe.Rn attempted several times to secure needle on syringe tip but would not make properly seal.Lot#: 2011005, 2011009, 2007005.Product#: 305759.
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Material#: 305759, lot#: 2011005 ,2011009, 2007005.It was reported by the customer that they noticed the medication was leaking out.Verbatim: rcc received a complaint via email.Email(s) attached.Quality issue product performance (leaking).When the nurses start injecting medications, they noticed the medication was leaking out.No patient injury reported.On nov 30 ¿ towards the completion of a subcutaneous injection of chemotherapy (bortezomib), i noted a single small drop of the drug that leaked onto the patient's skin as i was slowly injecting the drug.I immediately stopped pushing on the syringe plunger to prevent loss of any more drug / fluid.Dec 5 ¿ atropine leaked out of the syringe.The needle would not connect properly with the syringe.Dec 12 ¿ one drop of bortezomib came out of connection of the needle and equashield, unable to estimate how much in volume.Dec 18 ¿ vitamin b12 injection being administered to pt.Lot # 2011005 25g x 5/8 needle adapter (bd eclipse needle) was used during administration.Upon administration writer noticed minimal leakage at connection site between needle adaptor and syringe.Administration stopped.Feb 2 - rn went to connect 25g needle to 10mls syringe of daratumumab and needle would not secure properly on the syringe.Rn attempted several times to secure needle on syringe tip but would not make properly seal.Lot#: 2011005, 2011009, 2007005.Product#: 305759.Follow up: 1.Please confirm the exact location of leakage/damage.My understanding is that a needle would not connect/screw with a syringe properly.Medications are leaking out where the needle is connected to the syringe.No minor damage to anyone, but we are injecting cytotoxic drugs at our clinic.This is a huge hazard for both providers (nurses) and the patients.2.Please confirm a product is still operable or not? no.Due to the leakage, the product is not operable.The user (nurses) won't be able to give a full dose.3.Did the event directly, or indirectly involve a patient or user? yes, a direct impact on the patients.Due to the leakage, the patients won't be able to receive a full dose.4.If patient impact, please provide any available patient information including: age/ date of birth, sex, weight, ethnicity, race, other relevant history including preexisting medical conditions.I don't think this is a relevant information to these incidents.2 out of 5 patients were receiving bortezomib injection which is a treatment for multiple myeloma 5.Is there any physical sample or sample photos/videos available? if yes, kindly share it for investigation.No.6.Can you please share the batch number according to date of event? because for this complaint there is 5 date of event and 3 lot numbers provided.Dec 5 2023 - 2011009.Dec 12 2023 - 2011005.Nov 30 2023 - unknown.Dec 18 2023 - 2011005.Feb 2 2024 - 2007005.7.Can please provide the customer address for samples? (b)(6).
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