The reported event was confirmed, however, the cause is unknown.Visual evaluation of the returned sample noted one opened (without original packaging), bulb irrigation syringe.Visual inspection of the sample noted a plug of glue-like foreign material (distinct from the syringe body material) completely blocking the syringe port and preventing drainage.According to the appropriate drawing, the syringe barrel port diameter is 0.265 inches +/- 0.005 inches, and thus the foreign material measures at least 0.260 inches.This is out of specification per inspection procedure which states, "loose foreign matter or embedded shall not exceed an aggregate total of 0.6mm² or 1/16¿ per the dirt estimation chart." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿no follow up to the production areas cleaning procedure.¿ the device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.
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