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Person attempting to give epipen was punctured in finger / upon removing blue cap, needle immediately emerged [injury associated with device].Needle was bent [needle issue].Needle immediately emerged / needle would not retract [device deployment issue].It did not appear any medication was distributed [device delivery system issue].Case narrative: this regulatory report concerns of events of injury associated with device, needle issue, device deployment issue and device delivery system issue in a patient (age, gender and race were not reported) from the united states.The patient's age at the time of experience was not reported.On (b)(6) 2024, amneal pharmaceuticals received information from the other reporter via an email through the regulatory authority us food and drug administration, with reference number (b)(4) concerning above-mentioned events experienced while on amneal's twinject (epinephrine auto-injector).The patient was being treated with epinephrine auto-injector 0.3mg (ndc: 0115-1694-30) (dose, frequency and therapy date not reported) for unknown indication.Patient allergic to bee sting.Concurrent condition included bee stung.Concomitant medications, medical history, history of procedures and surgeries, history of smoking/alcohol consumption, recreational drug use and laboratory tests were not reported.It was reported that the epipen 0.3 was attempted to be given to person stung by bee with known allergy.Upon removing blue cap, needle immediately emerged and was bent.Person attempting to give epipen was punctured in finger.It did not appear any medication was distributed, and needle would not retract.It was not expired.Person with allergy taken to hospital.Last action taken with epinephrine in relation to injury associated with device was unknown.De-challenge and re-challenge were unknown.Last action taken with epinephrine in relation to needle issue, device deployment issue and device delivery system issue was not applicable.De-challenge and re-challenge were not applicable.The outcome for the events of injury associated with device, needle issue, device deployment issue and device delivery system issue were unknown.The reporter causality for the events injury associated with device, needle issue, device deployment issue and device delivery system issue was not reported.This case was considered as serious.The reportability of this case was expedited.
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Person attempting to give epipen was punctured in finger / upon removing blue cap, needle immediately emerged [injury associated with device] needle was bent [needle issue] needle immediately emerged / needle would not retract [device deployment issue] it did not appear any medication was distributed [device delivery system issue].Case narrative: this regulatory report concerns of events of injury associated with device, needle issue, device deployment issue and device delivery system issue in a patient (age, gender and race were not reported) from the united states.The patient's age at the time of experience was not reported.On (b)(6)2024, amneal pharmaceuticals received information from the other reporter via an email through the regulatory authority us food and drug administration, with reference number ((b)(4)) concerning above-mentioned events experienced while on amneal's twinject (epinephrine auto-injector).The patient was being treated with epinephrine auto-injector 0.3mg (ndc: (b)(4)) (dose, frequency and therapy date not reported) for unknown indication.Patient allergic to bee sting.Concurrent condition included bee stung.Concomitant medications, medical history, history of procedures and surgeries, history of smoking/alcohol consumption, recreational drug use and laboratory tests were not reported.It was reported that the epipen 0.3 was attempted to be given to person stung by bee with known allergy.Upon removing blue cap, needle immediately emerged and was bent.Person attempting to give epipen was punctured in finger.It did not appear any medication was distributed, and needle would not retract.It was not expired.Person with allergy taken to hospital.Last action taken with epinephrine in relation to injury associated with device was unknown.De-challenge and re-challenge were unknown.Last action taken with epinephrine in relation to needle issue, device deployment issue and device delivery system issue was not applicable.De-challenge and re-challenge were not applicable.The outcome for the events of injury associated with device, needle issue, device deployment issue and device delivery system issue were unknown.The reporter causality for the events injury associated with device, needle issue, device deployment issue and device delivery system issue was not reported.This case was considered as serious.The reportability of this case was expedited.This significant follow up (#1) information received on 17-sep-2024.New information received includes qa investigation report, attached with this case.On (b)(6) 2024, amneal product complaints received a product complaint notification for epinephrine auto- injector 0.3 mg, lot unknown, ¿needle immediately emerged and was bent¿.The investigation complaint sub-type based on the complaint information was determined to be for defective injector and bent needle.The cmo pfizer investigation was not warranted as the complaint was related to the assembly and packaging of the device at phillips.An investigation was performed by phillips for the subject lot.After review of the manufacturing controls in place, pmm does not see a correlation between technical (b)(4) and the manufacturing process at pmm.The controlled annual product reports from (b)(6) 2021, to (b)(6) 2023, were reviewed for deviations/investigations that could have contributed to the complaint.There were no deviations/discrepancies found that may have led to the defect reported by the customer.All in-process and final release criteria were met for all lots manufactured at phillips-medisize.There have been 12 other, similar complaints reported in the complaint category bent needle in the past 24 months.None of the (b)(4) similar complaints were attributable to the manufacturing process.There have been (b)(4) other, similar complaints reported in the complaint category defective injector in the past 24 months.None of the (b)(4) similar complaints were attributed to the manufacturing process.Note complaints are assigned the subtype of defective injector when detail surrounding the event lack details to determine a more specific complaint sub-type.A review of the pfmea was completed to confirm if the failure modes are captured within the current assembly process.The complaint sample was not returned for evaluation as such could not be confirmed.Controls are in-place to assure needles do not exceed an angle of 2 degrees from straight.The device is designed such that the needle remains unexposed (within the nose cap) until after administration of the dose.Post-administration, the needle protrudes from the red nose cap when removed from the patient¿s thigh.If not removed from the thigh properly (pulled straight out), then there is a potential for the needle to bend.The approved instructions for use state, ¿place the red tip against the middle of the outer thigh (upper leg) at a 90- degree angle (perpendicular) to the thigh.Press down hard and hold firmly against the thigh for approximately 10 seconds to deliver the medicine.Only inject into the middle of outer thigh.Do not inject into any other part of the body.Remove epinephrine injection from the thigh.As part of post marketing requirements ((b)(4)), a total of (b)(4) devices were tested during dose reliability testing for pmr (b)(4).Bent needles were not seen when the insertion and removal angles were kept the same.Needle angles were primarily influenced by rotation of an activated device prior to removal.This finding indicates that the most likely causal factor for reported bent needle complaints is not attributed to the manufacturing process but rather due to the handling by end users.Adequate controls are in place to prevent the potential of bent needle defects being generated and going undetected in the manufacturing process.To address defective injector for the reported upon removing blue cap, needle immediately emerged and was bent.Person attempting to give epipen was punctured in finger.It did not appear any medication was distributed and needle would not retract.In order for a device to fire and deploy the needle, two actions must be performed on the device by the user.The blue safety cap must be removed from the end of the device, the safety cap when in place on the device ensures the device will not fire, as it is a safety mechanism.In addition, the blue sheath remover must be removed from the needle end.The sheath remover with sheath in place on the device will not allow a device to fire as the sheath remover prevents the internal firing mechanism from engaging.When both blue caps (safety cap and sheath remover) are removed the device is active and ready to fire.The unit would then need a force applied to the body of the device with the red needle end (red nose cap) positioned against a solid area to fire.Per the instructions for use (ifu), pull off both blue caps, push red tip hard in thigh for 10 seconds, in addition.The ifu states, the two blue end caps on epinephrine injection help to prevent accidental injection of the device.Do not remove the two blue end caps until you are ready to use it.In addition, the needle of the amneal epinephrine auto-injector does not retract per design.The ifu provides instructions for post-administration storage of the device back into the carrying case.As there was a lack of details for the reported complaint and the complaint sample was not returned a root cause related to user error could not be determined.The investigation associated with epinephrine injection usp auto-injector 0.3 mg, lot unknown for the complaint category ¿defective injector; bent needle, confirmed all autoinjectors were manufactured in accordance with approved batch records and met specification for release.The complaint sample was not returned for evaluation, as such the complaint could not be confirmed.Based on prior studies, bent needle complaints are not attributed to the manufacturing process but rather due to the handling by end users.Adequate controls are in place to prevent the potential of bent needle defects being generated and going undetected in the manufacturing process.As there was a lack of details for the reported complaint and the complaint sample was not returned a root cause related to user error could not be determined.There were no issues related to the manufacturing or assembly process that were determined to be attributed to the reported complaint.All auto-injectors released to market were manufactured in accordance with approved batch records and met specifications for release.Last action taken with epinephrine in relation to injury associated with device was unknown.De-challenge and re-challenge were unknown.Last action taken with epinephrine in relation to needle issue, device deployment issue and device delivery system issue was not applicable.De-challenge and re-challenge were not applicable.The outcome for the events of injury associated with device, needle issue, device deployment issue and device delivery system issue were unknown.The reporter causality for the events injury associated with device, needle issue, device deployment issue and device delivery system issue was not reported.This case was considered as serious.The reportability of this case was expedited.This case has aepqc 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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