The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a breach in the seal was confirmed and the cause appeared to be supplier related.Three sealed securis stabilization devices with part number sec0100 and lot #asdxr001 were provided for investigation.The word ¿normal¿ was written on the packaging of two samples.¿complaint sample¿ was written on the packaging of the third sample.The device was not oriented correctly inside the packaging and the corner of the stabilization device was caught in the seal of the ¿complaint sample¿ packaging and was visible through a 1.0cm breach in the seal.The remainder of the seal was intact.The supplier was notified of this complaint.A lot history review (lhr) of asdxr001 showed no other similar product complaint(s) from this lot number.
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