H11: section a through f - 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.Based on a review of this information, the following was concluded: the complaint of bent needle was confirmed but the exact cause remains unknown.The product returned for evaluation was one 22g safestep infusion set.The returned product sample was evaluated and the needle was observed to be bent near the needle base.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use the tip of the needle bevel appeared unremarkable.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass the bent region of the needle.Based on the evidence provided with the returned sample it is unknown when or how the bend occurred in the needle.Damage to the needle could have occurred at the manufacturing facility, during shipping, during use, or during storage of the product, and no evidence was observed which supported a specific root cause of the event.H3 other text : evaluation findings are in section h11.
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