Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: outcomes attributed to adverse event: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: customer returned (2) 1cc, 6mm, 31g syringe in an open poly bag from lot#: 6355896.Customer states that the needle was bent, the tip of the syringe was broken, the insulin leaked, and the topper was loose.Both returned syringes were examined and one sample exhibited a bent cannula.One sample exhibited adhesive runoff onto the side of the barrel tip.However, no damage to the stoppers or any other defect that could lead to leakage was observed on the samples.Sample will be forwarded to manufacturing (holdrege) on 07sep2018 for further review.On 11sep2018, holdrege received two (2) 1ml, 6mm, 31g syringes in an opened polybag from batch#: 6355896.All samples are decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.The sample exhibiting adhesive run-over was visually inspected under ultraviolet lighting and confirmed the location of the adhesive along the outside edges of the barrel tip.The interior of the shield for the sample exhibiting a bent cannula was visually examined under 4x magnification and noted a single instance of damage to the shield's interior wall.This was likely caused during the initial shielding of the device.Probable root cause for bent cannula is likely to be a slight misalignment during the shield process, resulting in exacerbation of a pre-existing slight bend in the component.When this occurs, the result can be a bend that renders the device inoperable.Probable root cause for the adhesive run-over is likely to be a misalignment of the applicator nozzle to the barrel during delivery of the adhesive.When this type of event occurs, adhesive may be found along the exterior of the barrel tip, as well as down the barrel well.Capa: 226773 was initiated by the holdrege plant to address 1ml customer complaints, specifically bent cannula and cannula separates, and their associated root cause(s).Batch#: 6355896 was manufactured prior to initiation of this capa.No additional actions at this time.A review of the device history record was completed for batch#: 6355896.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle bent, barrel tip broken, leakage and damaged stopper on lot#: 6355896.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent cannula and adhesive runoff).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (leakage and damaged stopper).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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