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Occupation- spu incoming materials, primary and secondary packaging, gsk vaccines, gsk patient reported to be a child.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, investigation conclusions code 11 has been referenced in section h6.After review of the provided complaint information, two different defects are considered possible for this complaint: 1) cannula broken off during injection and 2) loose cannula (bonding between cannula and hub insufficient).No indications are available to determine which of these defects was more likely.Product packaging dates (30/11/2019 - 02/12/2019).Review of batch record for lot 1911029 (kn2516rb04) revealed that during needle assembly, as an in-process control, 40 assembled needles are visually inspected twice per shift for deformities/damages on the cannula and for gluing defects related to insufficient glue quantity.During production of the involved needle assembly batches approximately 5100 assembled needles were visually inspected.No defects related to this event were found during these visual inspections.Approximately 700 bonding strength tests were performed during production of the involved needle assembly batches where the strength is measured that is required to separate the cannula from the hub.All performed bonding strength test results were well within specification.Twenty retention samples from the involved lot were tested for bonding strength between the hub and the cannula.All results were well within the specification of at least 22n with a minimum test result of 141n.From the batch record review and retention sample investigation, no deviations or abnormalities were noted during production related to your complaint.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo europe n.V.(manufacturer) registration no.9681413.
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The user facility reported that the k-pack ii was used intra-operative.The needle became stuck inside the patient's thigh.The physician realized after injecting the vaccine that the cannula of the needle had disappeared.He thought it had fallen; however, as he could not find it, he sent the child for a thigh x-ray, which confirmed that the cannula was stuck inside.The child must undergo a surgery.The vaccine, priorix, was administered.
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This report is being submitted as follow up no.2 to provide a correction to section h6.Follow up no.1, section h6 investigation conclusions was inadvertently reported with code: 11; therefore, it has been updated to reflect the correct code: 4315.Several attempts have been done in a good faith effort to retrieve the device, however unfortunately with no success.
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This report is being submitted as follow up no.1 to update section h3, and to provide the retention sample investigation results.The mfr report # was inadvertently submitted as 9681834-2020-00002; on follow up no 1.However, the correct registration # is 9681413-2020-00002 and is therefore being resubmitted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Process investigation: with regards to this complaint, three vision inspection systems are in place to prevent the defect of this complaint to be processed further downstream in the process: 100% glue cone vision inspection system: this vision inspection system inspects the glue cone of every assembled needle.Assembled needles with a glue cone that is insufficiently large will be automatically rejected by the assembly line.100% needle point inspection: this vision inspection system detects assembled needles with a damaged needle point.Additionally, as the inspection window is very small, and the needle point needs to be within this inspection window to be judged as good, this inspection system will also detect cannula's that are too short, too long, tilted due to a damage on the line or tilted due to insufficient depth of cannula in hub shaft (if the cannula is not inserted deep enough in the hub shaft, it will be tilted as it will not withstand the small pressure to the cannula that is applied during gluing).100% no hole inspection system: this vision inspection system inspects all assembled needles for blockages.If the cannula is not inserted deep enough into the hub shaft, glue will block the lumen between cannula and hub.Additionally, also for tilted cannulas, the vision inspection will not be able to "see" through the cannula properly and will reject the assembled needle.Note: damages to the cannula that have an impact that is strong enough for the cannula to break after/during use, that can be caused by the terumo europe manufacturing process, will most likely also lead to tilted cannulas.During needle assembly, as an in-process control, 40 assembled needles are visually inspected twice per shift for deformities/damages on the cannula and for gluing defects related to insufficient glue quantity.During production of the involved needle assembly batches approximately 5100 assembled needles were visually inspected.No defects related to the reported event were found during these visual inspections nor during other in process controls/final inspections.Additionally, approximately 700 bonding strength tests were performed during production of the involved needle assembly batches where the strength is measured that is required to separate the cannula from the hub.This measurement is not only relevant for determining strength of the adherence of the different components to the glue (hub and cannula) but also a relevant measurement for strength of the cannula just above the glue cone.All performed bonding strength test results were well within specification.The bonding strength during production of the involved needle assembly batches was well above the out of specification limit.Additionally, the supplier of the cannula batches confirmed that no atypical observations, no deviations or non-conformities were reported during production of the involved cannula batches.Retention sample investigation: twenty (20) retention samples from the involved lot 1911029 were tested by for bonding strength between the hub and the cannula.The lowest test result of these 20 samples was 141n which is well above the specification of minimum 22n.Investigation of complaint database: the complaint database was reviewed for similar complaints (cannula broken or cannula detached/loose) from the past 3 years (period 22/12/2017 to 22/12/2020).(b)(4).No complaint sample nor pictures were received.This complaint could not be confirmed to be related to the terumo europe manufacturing process.Based on investigation of the complaint database, for the period of the last three years during which more than (b)(4) kn needles were released to market, no complaints similar to your complaint were reported and confirmed to be related to the terumo europe manufacturing process.Investigation of rejection rate of relevant online inspections: the reject rate of the glue cone inspection system is the only relevant online inspection system for which the reject rate can be potentially directly related to this complaint.This inspection is an automatic inspection for presence of glue cone.Samples without a glue cone are rejected.However, as the glue cone itself does not have direct impact on bonding strength between hub and cannula oot values detected during production are a performance issue and not a quality issue.The inspection cannot detect too much glue as the maximal size of the glue cone is only limited (excess glue will run off) the glue cone can never be too large.Too much glue does not have an impact on curing as all glue will be cured, including the runoff glue.Review of the reject rate for this inspection revealed that during production of the involved needle assembly batches, the reject rate was within the oos trend limit.(note: trend limits are defined based on historical performance / date for the production line).These rejection rates are well within the capabilities of the inspection system.Both na11 and na14 are considered equivalent as they use the same technology, process and materials.The observed oot difference between both lines can be explained by the fact that the involved item is run more frequently on na11 and that for the illustrated time period, more data points are available for na11 (244 data points) when compared to na14 (46 data points).The difference in performance, however, is limited which is illustrated by the oot limits which are comparable for both lines and which are based on a larger set of data.No oot's were noticed on both lines for the involved production period.The oot values reported on na11 just after production of the involved batch are not considered relevant as no intervention was performed, they are considered part of the inherent variation of the process.Only for the 3rd oot a slight modification of the glue settings within the allowed tolerances was performed to reduce waste.From the batch record review, retention sample investigation, investigation of raw materials, investigation of the complaint database and investigation of rejection rate of relevant online inspections, no deviations or abnormalities were noted during production related to the reported event.Based on the performed investigation: a loose cannula is considered practically impossible; a broken cannula is possible but the past three years; no complaints were received that could be confirmed to be potentially related to the terumo europe manufacturing process.Further investigation is only possible after the sample has been received.Potential occurrence rate can only be defined once the actual defect/ failure mode has been determined and the related root cause has been defined.
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