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Accidently the needle was injected to the thumb finger [accidental exposure to product] nurse was left with a bloody puncture wound [puncture site haemorrhage], spring failed [device malfunction] , needle was bent [needle issue].Case narrative: this initial spontaneous report concerns of adverse events accidental exposure to product and device malfunction and in a patient (nurse) (age, gender and race were not reported) from the united states.The patient's age at the time of event experience was not reported.On 30-apr-2025, amneal pharmaceuticals received information from the office manager via an email concerning above-mentioned event experienced by the patient while on amneal's twinject (epinephrine auto-injector).Significant follow-up (#1) information received on 02-may-2025 from office manager via an email.Additional information included new event needle issue was added to the case and narrative was updated.The patient (nurse) accidently injected epinephrine auto-injector 0.3 mg (ndc: 0115-1694-30, batch no: g240305x, exp date: 31-oct-2025, and serial number was not reported) (dose, route, frequency, and therapy dates were not reported) while administering it to patient.Concurrent conditions, co-suspect medication, concomitant medications, medical history, allergy, history of procedures, smoking, alcohol consumption, recreational drug use, and laboratory tests were not reported.On an unknown date, the patient who had anaphylactic reaction received the epi pen from pharmacy and while administration to the patient accidently the needle was injected to the thumb finger of the nurse after that the needle bent and it was confirmed by reporter that the second epinephrine injection administered to the patient and the patient did not miss the dose.It was further reported that the auto-injector was stored in carrying case and auto-injector instructions were read before use, first they removed sheath remover and cap was pulled off, secondly safety cap was pulled off and then nose cap was visible but nose cap was not placed on the outer thigh of the patient, instead spring of auto-injector failed and went backwards into the thumb of the nurse.Last action taken with epinephrine in relation to accidental exposure to product, device malfunction and needle issue was not applicable.De-challenge and re-challenge were not applicable.The outcome of events accidental exposure to product, device malfunction and needle issue was unknown.The reporter did not assess the causality of accidental exposure to product, device malfunction and needle issue with epinephrine.This case was considered as serious.The reportability of this case was expedited.This significant follow up (#2) information received on 20-may-2025.New information received includes qa investigation report, attached with this case.Additional significant information received on 23-may-2025.Significant information received from other reporter via an email through the regulatory authority us food and drug administration, with reference number (aer: (b)(4).Additional information included new event puncture site haemorrhage was added to the case and narrative was updated.An investigation was conducted in response to a complaint categorized as ¿bent needle¿ associated with the epinephrine auto-injector.Based on the reported complaint for ¿the needle was bent¿, bent needle complaints is not attributed to the manufacturing process or device malfunction, but rather due to the handling by end users post injection, hence the root cause is potential user error.Adequate controls are in place to prevent the potential of bent needle defects being generated and going undetected in the manufacturing process.The complaint of a ¿bent needle¿ was verified; however, all evidence indicates that the deformation occurred post-use due to improper reinsertion of the device into the carrying case.This is further supported by previous post marketing studies, which have shown that bent needles are frequently associated with changes in insertion/removal angles and rotational forces applied after activation.No component failure or functional malfunction was identified that would suggest a manufacturing issue or design defect.A comprehensive review of all in-process controls and final release data from phillips-medisize for the subject lot manufactured demonstrated full compliance with applicable specifications and approved batch records.The reported complaint was not observed in the retain review as the device tested, confirmed.There were no anomalies or deviations noted during manufacturing, assembly, or packaging that could have contributed to the reported complaint.Labeling components, including the instructions for use (ifu), were reviewed and confirmed to clearly depict the proper administration methods through both images and verbiage.The investigation found no evidence linking the manufacturing process, assembly, or packaging to the reported failure.The subject lot released to market was produced in accordance with current approved specifications and procedures.It was reported that, after accidentally injecting epi pen (nurse), was left with a bloody puncture wound.Last action taken with epinephrine in relation to accidental exposure to product, puncture site haemorrhage, device malfunction and needle issue was not applicable.De-challenge and re-challenge were not applicable.The outcome of events accidental exposure to product, puncture site haemorrhage, device malfunction and needle issue was unknown.The reporter did not assess the causality of accidental exposure to product, puncture site haemorrhage, device malfunction and needle issue with epinephrine.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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