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Medication is left in pen [incorrect dose administered] needle didn't come out [device failure] medication was leaking [device leakage] case narrative: this initial spontaneous report concerns of events incorrect dose administered, device failure and device leakage in a 42-year-old female patient (race not reported) from the united states.The patient's age at the time of experience was 42 years.On (b)(6) 2024, amneal pharmaceuticals received information from patient via an email concerning above-mentioned event experienced while on amneal's twinject (epinephrine auto-injector).Additional follow-up (#1) information received on 23-sep-2024.Additional information received from patient via an email.Additional information included narrative was updated.The patient was using epinephrine injection usp 0.30 mg (auto-injector) (dose, frequency, route and therapy dates not reported) (batch no.G240304x, expiry date- 31-aug-2025) for allergic reaction to bee.Concurrent condition included allergic reaction to bee.Allergies included hydrocodone, erythromycin, morphine drug allergy and red dye allergy.Co-suspect medication, concomitant medication, medical history, current condition, history of procedures/ surgeries, history of smoking, alcohol consumption and recreational drug use were not reported.Laboratory tests were not reported.It was reported that, on an unknown date patient received sealed medication from pharmacy and on (b)(6) 2024 she got allergic reaction because of bees and her friend opened her handbag and injected first epipen to right thigh and noticed medication was leaking and some medication is left in pen so, her friend tired second epipen to her thigh and placing 10 second she heard click sound and when she removed the pen she noticed needle didn't come out and she stated she still not recovered from allergic reaction.Further patient¿s friend took her to near emergency room and doctors gave another epipen and mentioned she recovered from the event.It was reported that there was a needle puncture in the skin after administering the medicine.Last action taken with epinephrine in relation to incorrect dose administered, device failure and device leakage was not applicable.De-challenge and re-challenge were not applicable.The outcome of device failure, device leakage, incorrect dose administered and no adverse event was not recovered.The reporter did not assess the causality of events device failure, device leakage, incorrect dose administered and no adverse event to epinephrine.This case was considered as serious.The reportability of this case was expedited.
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Medication is left in pen [incorrect dose administered] needle didn't come out [device failure] medication was leaking [device leakage] case narrative: this initial spontaneous report concerns of events incorrect dose administered, device failure and device leakage in a 42-year-old female patient (race not reported) from the united states.The patient's age at the time of experience was 42 years.On (b)(6) 2024, amneal pharmaceuticals received information from patient via an email concerning above-mentioned event experienced while on amneal's twinject (epinephrine auto-injector).Additional follow-up (#1) information received on 23-sep-2024.Additional information received from patient via an email.Additional information included narrative was updated.The patient was using epinephrine injection usp 0.30 mg (auto-injector) (dose, frequency, route and therapy dates not reported) (batch no.G240304x, expiry date- 31-aug-2025) for allergic reaction to bee.Concurrent condition included allergic reaction to bee.Allergies included hydrocodone, erythromycin, morphine drug allergy and red dye allergy.Co-suspect medication, concomitant medication, medical history, current condition, history of procedures/ surgeries, history of smoking, alcohol consumption and recreational drug use were not reported.Laboratory tests were not reported.It was reported that, on an unknown date patient received sealed medication from pharmacy and on (b)(6) 2024 she got allergic reaction because of bees and her friend opened her handbag and injected first epipen to right thigh and noticed medication was leaking and some medication is left in pen so, her friend tired second epipen to her thigh and placing 10 second she heard click sound and when she removed the pen she noticed needle didn't come out and she stated she still not recovered from allergic reaction.Further patient¿s friend took her to near emergency room and doctors gave another epipen and mentioned she recovered from the event.It was reported that there was a needle puncture in the skin after administering the medicine.Last action taken with epinephrine in relation to incorrect dose administered, device failure and device leakage was not applicable.De-challenge and re-challenge were not applicable.The outcome of device failure, device leakage, incorrect dose administered and no adverse event was not recovered.The reporter did not assess the causality of events device failure, device leakage, incorrect dose administered and no adverse event to epinephrine.This case was considered as serious.The reportability of this case was expedited.This significant follow up (#2) information received on 08-oct-2024.New information received includes qa investigation report, attached with this case.On 18 sep 2024, amneal product complaints received a product complaint notification for epinephrine auto-injector 0.3 mg, lot g240304x, ¿needle did not come out of the pen¿.The investigation complaint sub-type based on the complaint information was determined to be for ¿failure to fire¿.The cmo pfizer investigation was not warranted as the complaint was related to the assembly of the device at phillips.An investigation was performed by phillips on the subject lot.A review of the pfmea was completed to confirm if the failure mode is captured within the current assembly process.Failure mode ¿failure to fire¿ is captured within the final sdeai assembly and nose cap sonic welding & assembly final vision inspection.No updates to the pfmea will be made as the current controls in place capture the defect mode identified in the complaint.There have been no other complaints reported for lot g240304x for the past 24 months.There have been twenty-four (24) other, similar complaints reported in the complaint category ¿failure to fire¿ in the past 24 months.None of the 24 similar complaints were attributed to the manufacturing process.Retain review conformed, sample tested fire properly and delivered a dose.Based on the retain review the reported complaint of was not confirmed.The complaint sample was returned on 02 oct 24 and inspected on (b)(6) 2024 from the sample return kit provided by impax - amneal.Two (2) 0.3 mg auto-injectors were returned, which included samples from lot g240304x exp aug 2025.Based on the complaint sample evaluation for the reported complaint was not confirmed as both samples #1 and #2 had been fired and delivered a dose.Evidence the device being fired and dose delivery were the following: the needle was projecting from the red nose cap, the spring release tines were not affixed to the firing bushing, the carpuject had approximately 0.8 ml of solution remaining and the dose adjustment screw was in contact with the stop collar.In addition, skin tissue residue was observed on the needle of sample #2 which confirmed the device was administered to the patient.There was no skin tissue observed on the needle of sample #1.As sample #1 was returned loose in the shipper with the needle exposed any residue could have been removed or added during transit.There were no defects observed in the complaint sample evaluation that would have prevented the user from administering the dose.Review of the instructions for use was performed, ¿pull off both blue caps.Put the red tip against the middle of the outer thigh at a 90 degree angle.Press down hard and hold firmly against thigh for approximately ten (10) seconds to deliver the medicine.Only inject into the middle of the outer thigh.Check the red tip.The injection is complete and you have received the correct dose of the medicine if you see the needle sticking out of the red tip.If you do not see the needle repeat steps.The instructions for use clearly detail the steps for administration of the device.As the complaint sample evaluation confirmed the device had been fired and administered to the patient, a potential root cause is failure to follow the instructions for use for administration of the dose.The investigation associated with epinephrine injection usp auto-injector 0.3 mg; lot g240304x for the complaint category ¿ failure to fire, for the reported complaint ¿needle did not come out of the pen¿ confirmed that the auto-injectors were manufactured in accordance with approved batch records.The evaluation of the retain sample conformed and met specification.Based on the complaint sample evaluation for the reported "needle did not come out of the pen" was not confirmed as the devices were returned in a fired state and delivered a dose.There was evidence on sample #2 the device was administered to the patient.The instructions for use clearly detail the steps for administration of the device.As the complaint sample evaluation confirmed the device had been fired and administered to the patient, a potential root cause is failure to follow the instructions for use for administration of the dose.There were no issues related to the manufacturing process that were determined to be attributed to the reported complaint.The investigation concluded that the lot released to market was manufactured in accordance with approved batch records and specifications.Last action taken with epinephrine in relation to incorrect dose administered, device failure and device leakage was not applicable.De-challenge and re-challenge were not applicable.The outcome of device failure, device leakage, incorrect dose administered and no adverse event was not recovered.The reporter did not assess the causality of events device failure, device leakage, incorrect dose administered and no adverse event to epinephrine.This case was considered as serious.The reportability of this case was expedited.This case has device complaint associated.The investigation report was assessed not to have the possibility of causing any future harm to other users of the product.
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