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When he pulled the blue cap off the white part covering the needle also came off [needle issue].Pen started to leak [device leakage].No adverse event [no adverse event].Case narrative: this initial spontaneous report concerns of needle issue, device leakage and no adverse event in a male patient (age and race not reported) from the united states.The patient's age at the time of experience was not reported.On (b)(6) 2023, amneal pharmaceuticals received information from the patient¿s wife via an email concerning above-mentioned events experienced while on amneal's twinject (epinephrine auto-injector).The patient was being treated with epinephrine injection usp 0.3 mg (auto-injector) (ndc: 0115-1694-49, serial number: (b)(6), batch/lot: g230711x and expiration date: feb-2025) (dose, frequency and therapy dates not reported) via subcutaneously for bee allergy.Concurrent condition was included as bee allergy.Co-suspect medication, concomitant medication, medical history, 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, the patient got epinephrine pens for bee allergy.He had to use it one afternoon, but he was not able to inject the first pen.When he pulled the blue cap off the white part covering the needle also came off and the pen started to leak.Last action taken with epinephrine in relation to needle issue, device leakage and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of needle issue, device leakage and no adverse event were unknown.The reporter assessed the causality of events needle issue, device leakage and no adverse event as not reported.This case was considered as serious.The reportability of this case was expedited.This significant follow up (#1) information received on 18-nov-2023.New information received includes qa investigation report, attached with this case.On 03 nov 2023, amneal product complaints received a product complaint notification for epinephrine auto-injector 0.3 mg, lot g230711x, ¿patient was unable to inject first pen as white part came off and the pen started leaking¿.The investigation complaint sub-type based on the complaint information was determined to be ¿defective injector¿.A cmo pfizer investigation was not warranted as the complaint was related to the assembly and packaging at the cpo phillips (pmm).Phillips performed an investigation of 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.Per the electronic batch record, all in-process inspections and qa release samples testing met acceptable criteria, there were no deviations or discrepancies found during the 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.There have been no other complaints reported for lot g230711x for the past 24 months.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.Based on the retain review and testing, the retains 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 sample was returned for evaluation.The reporter did provide four (4) photos.The photos were reviewed and the reported complaint of "the white part covering the needle also came off and the pen started to leak " was not confirmed as there were no photos of the needle end to review.A root cause of user error could not be determined based on the photos provided.The investigation associated with epinephrine injection usp auto-injector 0.3 mg, lot g230711x for the complaint category ¿defective injector¿, for the reported complaint determined the manufacturing, assembly or packaging did not contribute to the reported complaint.A retain review was performed and the product conformed.The complaint sample was not returned; however, photos were provided.Based on the photos the root cause of the reported complaint could not be determined as the photos of the needle end were not provided.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, device leakage and no adverse event was not applicable.De-challenge and re-challenge were not applicable.The outcome of needle issue, device leakage and no adverse event were unknown.The reporter assessed the causality of events needle issue, device leakage and no adverse event as not reported.This case was considered as serious.The reportability of this case was expedited.
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