| Lot Number |
G250204X |
| Medical Device Problem Code |
Defective Device (2588)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
09/24/2025
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Type of Reportable Event
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Malfunction
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Event or Problem Description
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Despite pulling both caps, the epi pen needle did not come out when injected into my thigh, instead i faced resistance with a giant plastic cap that i assume was capping the needle [device failure] , no adverse event [no adverse event].Case narrative: this initial spontaneous report concerns of adverse events device failure and no adverse event in patient (age, gender and race not reported) from the united states.The patient's age at the time of event experience was not reported.On 25-sep-2025, amneal pharmaceuticals received information from the patient via an email concerning above-mentioned events experienced by the patient while on amneal's epinephrine auto-injector.On (b)(6) 2025, the patient was being treated with epinephrine auto-injector 0.3 mg (ndc: 0115-1694-30, batch no: g250204x, exp date: 31-aug-2026) via subcutaneous route for anaphylactic reaction to nuts.Concurrent conditions included anaphylactic reaction to nuts.Co-suspect medication, concomitant medications, medical history, history of procedures and surgeries, history of allergies, history of smoking/drinking, historical drug and recreational drug use were not reported.Laboratory tests were not reported.On (b)(6) 2025 (previous night of this report), the patient attempted to use the epinephrine auto-injector after experiencing an anaphylactic reaction to nuts.The patient stated that despite pulling both caps, the epipen needle did not come out when injected into the thigh.Instead, the patient encountered resistance with a giant plastic cap that appeared to be capping the needle.The patient explained that every time the patient had used this brand in the past and pulled the bottom cap, the red ¿needle end¿ was visible and could then be jabbed into the thigh, allowing the needle to come out once the red part was pressed against the skin.However, this time, instead of the needle, a plastic piece came out, preventing proper injection.The patient further stated that, after pulling the needle-end blue cap, only the red end remained with no needle sticking out.Upon jabbing the red end into the thigh, the needle would usually extend into the skin and remain out.The patient reported that this was the first time the plastic piece stayed on, preventing the needle from deploying and resulting in failure of injection.Last action taken with epinephrine auto-injector in relation to device failure and no adverse event were not applicable.De-challenge and re-challenge were not applicable.The outcome of events, device failure and no adverse event were unknown.The reporter did not provide the causality of events device failure and no adverse event with epinephrine auto-injector.This case was considered serious.The reportability of this case was expedited.
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Event or Problem Description
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Despite pulling both caps, the epi pen needle did not come out when injected into my thigh, instead i faced resistance with a giant plastic cap that i assume was capping the needle [device failure] no adverse event [no adverse event].Case narrative: this initial spontaneous report concerns of adverse events device failure and no adverse event in patient (age, gender and race not reported) from the united states.The patient's age at the time of event experience was not reported.On 25-sep-2025, amneal pharmaceuticals received information from the patient via an email concerning above-mentioned events experienced by the patient while on amneal's epinephrine auto-injector.On 24-sep-2025, the patient was being treated with epinephrine auto-injector 0.3 mg (ndc: 0115-1694-30, batch no: g250204x, exp date: 31-aug-2026) via subcutaneous route for anaphylactic reaction to nuts.Concurrent conditions included anaphylactic reaction to nuts.Co-suspect medication, concomitant medications, medical history, history of procedures and surgeries, history of allergies, history of smoking/drinking, historical drug and recreational drug use were not reported.Laboratory tests were not reported.On 24-sep-2025 (previous night of this report), the patient attempted to use the epinephrine auto-injector after experiencing an anaphylactic reaction to nuts.The patient stated that despite pulling both caps, the epipen needle did not come out when injected into the thigh.Instead, the patient encountered resistance with a giant plastic cap that appeared to be capping the needle.The patient explained that every time the patient had used this brand in the past and pulled the bottom cap, the red ¿needle end¿ was visible and could then be jabbed into the thigh, allowing the needle to come out once the red part was pressed against the skin.However, this time, instead of the needle, a plastic piece came out, preventing proper injection.The patient further stated that, after pulling the needle-end blue cap, only the red end remained with no needle sticking out.Upon jabbing the red end into the thigh, the needle would usually extend into the skin and remain out.The patient reported that this was the first time the plastic piece stayed on, preventing the needle from deploying and resulting in failure of injection.Last action taken with epinephrine auto-injector in relation to device failure and no adverse event were not applicable.De-challenge and re-challenge were not applicable.The outcome of events, device failure and no adverse event were unknown.The reporter did not provide the causality of events device failure and no adverse event with epinephrine auto-injector.This case was considered serious.The reportability of this case was expedited.This significant follow up (#1) information received on 17-oct-2025.New information received includes qa investigation report, attached with this case.At the time of the investigation report the complaint sample had been returned but the evaluation had not been completed.Once the evaluation is completed and shared with phillips both the amneal and phillips investigations will be amended.The reporter supplied a photo of the complaint sample.A complaint was received stating the ¿epi needle did not come out, there was a plastic cap.¿ during use.A photograph of a 0.3 mg epinephrine auto-injector (lot g250204x, exp.31-aug-2026) showed the device in a fired state with the needle extended and liquid visible in the sheath.The sheath bulb tip appeared intact.No images of the sheath remover or safety cap were provided.Based on the photo, the device may have discharged with the sheath attached, but this cannot be confirmed.Root cause could not be determined from the limited evidence.Phillips (pmm) investigation found no assembly or in-process deviations, and both in-process and final release testing met specifications.Retain samples were fully functional.Review of instructions for use (ifu) and labeling confirmed adequate directions and pictorials for sheath removal.This is the first complaint reported for lot g250204x with complaint defect unconfirmed.Complaint history review identified 12 other similar ¿sheath not removed¿¿ reports in the past 24 months across 4.7 million devices released (frequency 0.00028%), none confirmed as product related.No anomalous trends were noted in the apr, or batch record reviews.The pfmea confirmed this failure mode is captured and risk controls remain appropriate.No product defect or manufacturing issue was identified.No capa is required; ongoing monitoring will continue.The lot released to market was produced in accordance with approved specifications and procedures.Last action taken with epinephrine auto-injector in relation to device failure and no adverse event were not applicable.De-challenge and re-challenge were not applicable.The outcome of events, device failure and no adverse event were unknown.The reporter did not provide the causality of events device failure and no adverse event with epinephrine auto-injector.This case was considered 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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Event or Problem Description
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Despite pulling both caps, the epi pen needle did not come out when injected into my thigh, instead i faced resistance with a giant plastic cap that i assume was capping the needle [device failure].No adverse event [no adverse event].Case narrative: this initial spontaneous report concerns of adverse events device failure and no adverse event in patient (age, gender and race not reported) from the united states.The patient's age at the time of event experience was not reported.On 25-sep-2025, amneal pharmaceuticals received information from the patient via an email concerning above-mentioned events experienced by the patient while on amneal's epinephrine auto-injector.On (b)(6) 2025, the patient was being treated with epinephrine auto-injector 0.3 mg (ndc: 0115-1694-30, batch no: g250204x, exp date: 31-aug-2026) via subcutaneous route for anaphylactic reaction to nuts.Concurrent conditions included anaphylactic reaction to nuts.Co-suspect medication, concomitant medications, medical history, history of procedures and surgeries, history of allergies, history of smoking/drinking, historical drug and recreational drug use were not reported.Laboratory tests were not reported.On (b)(6) 2025 (previous night of this report), the patient attempted to use the epinephrine auto-injector after experiencing an anaphylactic reaction to nuts.The patient stated that despite pulling both caps, the epipen needle did not come out when injected into the thigh.Instead, the patient encountered resistance with a giant plastic cap that appeared to be capping the needle.The patient explained that every time the patient had used this brand in the past and pulled the bottom cap, the red ¿needle end¿ was visible and could then be jabbed into the thigh, allowing the needle to come out once the red part was pressed against the skin.However, this time, instead of the needle, a plastic piece came out, preventing proper injection.The patient further stated that, after pulling the needle-end blue cap, only the red end remained with no needle sticking out.Upon jabbing the red end into the thigh, the needle would usually extend into the skin and remain out.The patient reported that this was the first time the plastic piece stayed on, preventing the needle from deploying and resulting in failure of injection.Last action taken with epinephrine auto-injector in relation to device failure and no adverse event were not applicable.De-challenge and re-challenge were not applicable.The outcome of events, device failure and no adverse event were unknown.The reporter did not provide the causality of events device failure and no adverse event with epinephrine auto-injector.This case was considered serious.The reportability of this case was expedited.This significant follow up (#1) information received on 17-oct-2025.New information received includes qa investigation report, attached with this case.At the time of the investigation report the complaint sample had been returned but the evaluation had not been completed.Once the evaluation is completed and shared with phillips both the amneal and phillips investigations will be amended.The reporter supplied a photo of the complaint sample.A complaint was received stating the ¿epi needle did not come out, there was a plastic cap.¿ during use.A photograph of a 0.3 mg epinephrine auto-injector (lot: g250204x, exp.31-aug-2026) showed the device in a fired state with the needle extended and liquid visible in the sheath.The sheath bulb tip appeared intact.No images of the sheath remover or safety cap were provided.Based on the photo, the device may have discharged with the sheath attached, but this cannot be confirmed.Root cause could not be determined from the limited evidence.Phillips (pmm) investigation found no assembly or in-process deviations, and both in-process and final release testing met specifications.Retain samples were fully functional.Review of instructions for use (ifu) and labeling confirmed adequate directions and pictorials for sheath removal.This is the first complaint reported for lot: g250204x with complaint defect unconfirmed.Complaint history review identified 12 other similar ¿sheath not removed¿ reports in the past 24 months across 4.7 million devices released (frequency (b)(4), none confirmed as product related.No anomalous trends were noted in the apr, or batch record reviews.The pfmea confirmed this failure mode is captured and risk controls remain appropriate.No product defect or manufacturing issue was identified.No capa is required; ongoing monitoring will continue.The lot released to market was produced in accordance with approved specifications and procedures.Last action taken with epinephrine auto-injector in relation to device failure and no adverse event were not applicable.De-challenge and re-challenge were not applicable.The outcome of events, device failure and no adverse event were unknown.The reporter did not provide the causality of events device failure and no adverse event with epinephrine auto-injector.This case was considered 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.This significant follow up (#2) information received on 27-oct-2025.New information received includes qa investigation report.A complaint was received stating the ¿epi needle did not come out, there was a plastic cap.¿ during use.A photograph of a 0.3 mg epinephrine auto-injector (lot: g250204x, exp.31-aug-2026) showed the device in a fired state with the needle extended and liquid visible in the sheath.The sheath bulb tip appeared intact.No images of the sheath remover or safety cap were provided.Based on the photo, the device may have discharged with the sheath attached, but this cannot be confirmed.The reported complaint ¿epi needle did not come out; there was a plastic cap¿ was confirmed during the complaint sample evaluation.The sheath contained solution, and the needle was clean, indicating the sheath remained attached post-activation, preventing injection.However, the sheath detached during inspection, suggesting it had been removed in the field.Functional testing verified the sheath remover was capable of removing the sheath as designed; therefore, the condition is not considered a device malfunction.Both the sheath remover and safety cap were returned intact and functional.The firing mechanism functioned within specification, and the needle extended, confirming dose delivery internally.It is likely that the sheath was not removed at the time of intended use, resulting in failure to deliver the dose to the patient.The definitive root cause could not be determined, though user error remains a possible contributing factor.Evidence that the sheath was previously detached supports the possibility of reapplication in the field prior to activation.Phillips (pmm) investigation found no assembly or in-process deviations, and both in-process and final release testing met specifications.Retain samples were fully functional.Review of instructions for use (ifu) and labeling confirmed adequate directions and pictorials for sheath removal.This is the first complaint reported for lot: g250204x with complaint defect unconfirmed.Complaint history review identified 12 other similar ¿sheath not removed¿ reports in the past 24 months across 4.7 million devices released (frequency (b)(4) percent), none confirmed as product related.No anomalous trends were noted in the apr, or batch record reviews.The pfmea confirmed this failure mode is captured and risk controls remain appropriate.Based on the complaint sample evaluation the reported complaint ¿epi needle did not come out; there was a plastic cap¿ was confirmed during the complaint sample evaluation.The sheath contained solution, and the needle was clean, indicating the sheath remained attached post-activation, preventing injection.However, the sheath detached during inspection, suggesting it had been removed in the field.Functional testing verified the sheath remover was capable of removing the sheath as designed; therefore, the condition is not considered a device malfunction.It is likely that the sheath was not removed at the time of intended use, resulting in failure to deliver the dose to the patient.The definitive root cause could not be determined, though user error remains a possible contributing factor.Evidence that the sheath was previously detached supports the possibility of reapplication in the field prior to activation.No product defect or manufacturing issue was identified.No capa is required; ongoing monitoring will continue.The lot released to market was produced in accordance with approved specifications and procedures.Last action taken with epinephrine auto-injector in relation to device failure and no adverse event were not applicable.De-challenge and re-challenge were not applicable.The outcome of events, device failure and no adverse event were unknown.The reporter did not provide the causality of events device failure and no adverse event with epinephrine auto-injector.This case was considered serious.The reportability of this case was expedited.
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