Medical device expiration date: n/a.Medical device manufacturer: vip packaging.(b)(4).Initial reporter phone #: (b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A sample is not available for evaluation, however, a photo of the device was received and evaluated.The photo shows that a needle had pierced through the sharps container.Representative retention samples were also evaluated and both cavities were examined, in particular the region of the penetration.Cavity one measured 1.39mm in wall thickness and cavity two measured 1.33mm in wall thickness.These measurements are well above the minimum requirement of 1.17mm.A review of the device history record revealed no irregularities during the manufacture of the reported lot number 15126001.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.Device not returned for evaluation.
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