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Needle doesn't come out/ did not eject / a white tube came out and consumer can see the needle and it looks like the fluid inside of it [needle issue] no adverse event [no adverse event] case narrative: this initial spontaneous report concerns of needle issue and no adverse event in a 77-year-old female patient (age and race were not reported) from the united states.The patient's age at the time of experience was 77 years.On (b)(6) 2024, amneal pharmaceuticals received information from the patient via voice mail concerning above-mentioned events experienced while on amneal's twinject (epinephrine auto-injector).Additional significant information (#1) was received on (b)(6) 2024 from the patient via a telephonic call.New information included; patient details (demographics and current condition), product details (strength, product indication, lot number, expiry date and start date), event details (event verbatim and start date) and narrative has been added.The patient was being treated with epinephrine injection (auto-injector) 0.3 mg (ndc: 0115-1694-49, batch/lot: g221013x, expiration date: jul-2024) (dose and frequency) on (b)(6) 2024 for anaphylactic reaction.Concurrent condition includes anaphylactic reaction.Co-suspect medication, concomitant medication, medical history, history of procedures/ surgeries, history of allergies, history of smoking, alcohol consumption, recreational drug and laboratory tests use were not reported.On (b)(6) 2023 consumer purchased the sealed medication box from the pharmacy.On (b)(6) 2024, when she was about to inject the medication, she noticed that the needle doesn't come out.She stated that the auto-injector did not work and when she pressed the pen to her thigh, there was no needle.A white tube came out and consumer can see the needle and it looks like the fluid inside of it.Later, she tried to inject the other epipen, and it worked for her.She further mentioned that she did not miss her dose and she did not experience any adverse events.She also stated that she had used epipens many times over the past 15 years and she was familiar with the instruction of how to use.She denied providing the pictures of the defective epipen and further requested for the replacement.Last action taken with epinephrine in relation to needle issue and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of needle issue and no adverse event were unknown.The reporter causality for the events needle issue and no adverse event was not reported.This case was considered as serious.The reportability of this case was expedited.Follow-up (#2) information was received on 03-may-2024: follow-up information was received from the patient via a telephonic call.New information included; narrative was updated.It was reported that the consumer has used the epipen and confirmed that she was well aware of all the usage instructions.Further stated that both epipens were from same box.
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Needle doesn't come out/ did not eject / a white tube came out and consumer can see the needle and it looks like the fluid inside of it [needle issue].No adverse event [no adverse event].Case narrative: this initial spontaneous report concerns of needle issue and no adverse event in a 77-year-old female patient (age and race were not reported) from the united states.The patient's age at the time of experience was 77 years.On 28-apr-2024, amneal pharmaceuticals received information from the patient via voice mail concerning above-mentioned events experienced while on amneal's twinject (epinephrine auto-injector).Additional significant information (#1) was received on 29-apr-2024 from the patient via a telephonic call.New information included; patient details (demographics and current condition), product details (strength, product indication, lot number, expiry date and start date), event details (event verbatim and start date) and narrative has been added.The patient was being treated with epinephrine injection (auto-injector) 0.3 mg (ndc: (b)(4), batch/lot: g221013x, expiration date: jul-2024) (dose and frequency) on (b)(6) 2024 for anaphylactic reaction.Concurrent condition includes anaphylactic reaction.Co-suspect medication, concomitant medication, medical history, history of procedures/ surgeries, history of allergies, history of smoking, alcohol consumption, recreational drug and laboratory tests use were not reported.On (b)(6) 2023 consumer purchased the sealed medication box from the pharmacy.On (b)(6)2024, when she was about to inject the medication, she noticed that the needle doesn't come out.She stated that the auto-injector did not work and when she pressed the pen to her thigh, there was no needle.A white tube came out and consumer can see the needle and it looks like the fluid inside of it.Later, she tried to inject the other epipen, and it worked for her.She further mentioned that she did not miss her dose and she did not experience any adverse events.She also stated that she had used epipens many times over the past 15 years and she was familiar with the instruction of how to use.She denied providing the pictures of the defective epipen and further requested for the replacement.Last action taken with epinephrine in relation to needle issue and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of needle issue and no adverse event were unknown.The reporter causality for the events needle issue and no adverse event was not reported.This case was considered as serious.The reportability of this case was expedited.Follow-up (#2) information was received on 03-may-2024: follow-up information was received from the patient via a telephonic call.New information included; narrative was updated.It was reported that the consumer has used the epipen and confirmed that she was well aware of all the usage instructions.Further stated that both epipens were from same box.This significant follow up (#3) information received on 10-may-2024.New information received includes qa investigation report, attached with this case.On 28-apr-2024, amneal product complaints received a product complaint notification for epinephrine auto-injector 0.3 mg, lot g221013x, while trying to inject the needle was not coming out.The investigation complaint sub-type based on the complaint information was determined to be for sheath not removed by sheath remover.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.After review of the manufacturing controls in place, pmm does not see a correlation between technical complaint (b)(4) and the manufacturing process at pmm.All in-process testing met acceptable criteria, there were no deviations or discrepancies found during assembly of this lot that could have led to the defect reported by the customer.The lot met all acceptance criteria before release and distribution.As of 29-mar-2024, the receipt date of this complaint, there have been three (3) other complaints reported for lot g221013x for the past 24 months.A trend has been identified for lot g221013x, however based on the prior complaints the reported complaints were not confirmed.All retains reviewed met specification and conformed.All investigations concluded that the lot released to market was manufactured in accordance with approved batch records and specifications.There have been eleven (11) other, similar complaints reported in the complaint category sheath not removed by sheath remover in the past 24 months.None of the 10 similar complaints were attributed to the manufacturing process.Based on the retain review and testing the retain tested conformed, the reported complaint of was not confirmed.A review of the pfmea was completed to confirm if the failure mode is captured within the current assembly process.The complaint samples were returned on 08-may-2024 and inspected on 09-may-2024 from the complaint sample return kit provided by impax - amneal.Two (2) 0.3 mg epinephrine auto-injectors were returned, which included samples from lot g221013x exp jul-2024.Sample #1: based on the complaint sample evaluation of sample #1 the reported complaint while trying to inject the needle was not coming out was not confirmed as the sheath had been removed from the device by the user and there was evidence that the device was administered to the patient and delivered a dose.Sample #2: based on the complaint sample evaluation of sample #2 the reported complaint while trying to inject the needle was not coming out was not confirmed based on the functional evaluation performed by use of the returned sheath remover being able to remove the sheath.The instructions for use (ifu) were reviewed and there are adequate instructions for administration.As per the ifu, pull off both blue caps.You will now see a red tip.Grasp epinephrine injection in your fist with red tip pointing downward.(note, there is a picture in the ifu showing both blue caps being removed.The sheath remover photos show the sheath bulb tip as part of the sheath remover.) the needle comes out of the red tip.To avoid accidental injection, never put your thumb, fingers of hand over the red tip.If accidental injection happens, get medical help right away.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.If addition, there are instructions for after use disposal.As per the ifu, carefully cover the needle with the carrying case.(note, there is a picture in the ifu showing the device red needle tip with exposed needle) based on the lack of information provided on the users method of preparing the device for use and the evaluation of the complaint sample confirming that the sheath remover was capable of removing the sheath a root cause of user error could not be determined.The investigation associated with epinephrine injection usp auto-injector 0.3 mg, lot g221013x for the complaint category - sheath not removed by sheath remover; for the reported complaint while trying to inject the needle was not coming out determined the manufacturing or assembly did not attribute to the reported complaint.The reported complaint was not confirmed in the retain review.The complaint sample evaluation confirmed that sheath remover for sample #2 removed the sheath properly when functionally tested.There were no defects observed during the complaint sample evaluation which would have prevented the sheath not removed by the sheath remover.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 needle issue and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of needle issue and no adverse event were unknown.The reporter causality for the events needle issue and no adverse event was not reported.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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