Investigation summary: customer returned one syringe in an open poly bag from lot # 7058717 without the shield.Customer states that the barrel is bent, it would not draw, and the plunger is bent.The returned syringe was examined and exhibited a bent/dented barrel and a bent/dented plunger rod.This would cause the plunger to be difficult to move through the barrel.Sample will be forwarded to manufacturing ((b)(4)) on 15dec2017 for further review.Conclusion: an absolute root cause for this incident cannot be determined.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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Results - holdrege received one (1) 1ml, 8mm, 31g syringe without shield in opened polybag from batch# 7058717.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, it was noted that the received sample was without shield, resulting in a hooked cannula tip.The barrel of the sample exhibited a bowed appearance with stress fractures within the barrel wall, extending through the plunger rod as well.This type of damage is indicative of a likely jaw jam on the form fill & seal (ff&s).In such instances, any part or component of a syringe may be caught in the jam, resulting in damage to the component that generally renders the device inoperable by the end user.The damaged syringe and/or component(s) are typically found in the sealed polybag at a later time.Conclusion - as the sample was received without a shield upon initial investigation in franklin lakes, probable root cause is unable to be determined or identified to be a manufacturing related issue.
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