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Autoinjector did not work/nothing came out [device malfunction].No adverse event.Case narrative: this initial spontaneous report concerns of device malfunction and no adverse event in a female patient (age and race not reported) from the united states.The patient's age at the time of experience was not reported.On 28-sep-2023, amneal pharmaceuticals received information from the patient via a voicemail concerning above-mentioned event experienced while on amneal's twinject (epinephrine auto-injector).On an unknown date, the patient was using epinephrine injection usp (auto-injector) (strength, dose, frequency, route and therapy dates not reported) for an unknown indication.Co-suspect medication, concomitant medication, medical history, concurrent condition, history of procedures/ surgeries, history of allergies, history of smoking, alcohol consumption and recreational drug use were not reported.Laboratory tests were not reported.On an unknown date, while using epinephrine autoinjector the patient noticed that it did not work.Last action taken with epinephrine in relation to device malfunction and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of device malfunction and no adverse event were unknown.The reporter assessed the causality of events device malfunction and no adverse event as not reported.This case was considered as serious.The reportability of this case was expedited.Non-significant follow-up (#1) information was received on 29-sep-2023: follow up information was received from the patient via telephonic call.New information included; narrative information.The patient used her first epinephrine injection and noticed that medication did not come out from the injector and she used second epinephrine injection and confirmed it was fine.This significant follow up (#2) information received on 19-oct-2023.New information received includes qa investigation report, attached with this case.On 28 sep 2023, amneal product complaints received a product complaint notification for epinephrine auto-injector strength and lot unknown, "epinephrine autoinject epipen that did not work".The investigation complaint sub-type based on the complaint information was determined to be for "defective injector and lack of effect".The cmo pfizer and cpo phillips performed and investigation.The cmo pfizer performed an investigation for "lack of effect" on the cpjt lot unknown.The investigation included deviation investigations, an annual product record review, and an analysis of the complaint history for the reported product type.This product is received as api, compounded, manufactured, labeled, and bulk packaged by pfizer mcpherson.The unit is further assembled with the device component by the pc1 customer.Sub-class trending was performed for lack of effect in epinephrine with 15 complaints returned.None of the returned complaints have been determined as manufacture or vendor related.The final scope was determined to be an unknown lot of epinephrine.No quality issues were identified during the investigation.There is no impact on product quality.The compliant condition was not confirmed as no lot number or samples were returned; therefore, the root cause cannot be attributed to manufacturing or vendor processes.No corrective or preventative actions are required as the complaint condition was not confirmed.The cpo phillips performed an investigation for "defective injector" on the epinephrine auto-injector strength and lot unknown.The annual product reports from the past 24 months (september 29, 2021, to september 29, 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.Lot number is unknown; therefore, a complaint history of the lot cannot be completed.No reserve sample testing/review was conducted since the lot and batch are unknown for this complaint.A review of the pfmea was completed to confirm if the failure mode is captured within the current assembly process.The complaint sample was not returned for evaluation.A root cause related to user error could not be determined as details for the reported complaint were insufficient to determine cause, in addition and the complaint sample was not returned for evaluation, as such the reported complaint could not be confirmed.To address the medwatch report regarding the reporter stating, "that the instructions for use indicate that a trainer pen is to be included among the items in the box, however this trainer was not included." the ifu was reviewed and per the instructions in the pi/pil a trainer is not included with the 2-pack 0.3mg or 0.15mg epinephrine auto-injector carton.The 0.3mg strength states, "carton containing two epinephrine injection, usp 0.3 mg single-dose pre-filled auto-injectors: ndc 0115-1694-49" and the 0.15mg strength states, "carton containing two epinephrine injection, usp 0.15 mg single-dose pre-fi¬lled auto-injectors: ndc 0115-1695-49".In addition, the instructions state, "your epinephrine injection comes packaged in a carton containing 1 or 2 epinephrine injections.A separate epinephrine injection trainer is available.You may request a separate trainer, that comes packaged with instructions.Additional video instructions on the use of epinephrine injection are available from www.Epinephrineautoinject.Com.The investigation associated with epinephrine injection usp auto-injector strength and lot unknown for the complaint category - defective injector and lack of effect, for the reported complaint ¿epinephrine autoinject epipen that did not work¿ confirmed the in-process and final release criteria were met for all lots manufactured.There were no issues related to the manufacturing process that were determined to be attributed to the reported complaint.The investigation concluded that the lots released to market were manufactured in accordance with approved batch records and specifications.Last action taken with epinephrine in relation to device malfunction and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of device malfunction and no adverse event were unknown.The reporter assessed the causality of events device malfunction and no adverse event as 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.The impact on current and future users of product epinephrine cannot be assessed as the root cause of investigation remains undetermined as manufacturer or user error.Significant follow-up (#3) information was received on 18-oct-2023: follow up information was received via a letter through usfda.New information: patient name updated, current condition, event details and seriousness criteria added.Current condition included anaphylaxis.It was reported that the patient went into anaphylaxis on (b)(6) 2023 and attempted to self-inject using her epipen, but nothing came out.A friend was with her, and her friend was able to run and obtain a spare epipen and successfully administer the injection.The instructions for use indicated that a trainer pen had to be included among the items in the box, however this trainer was not included.She had a second box of epipen that were also without the trainer device despite instructions that indicate one should be included.Last action taken with epinephrine in relation to device malfunction and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of device malfunction and no adverse event were unknown.This case was considered as serious.The reportability of this case was expedited.
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