The reported event was confirmed.Visual inspection noted one opened syringe was received.Visual evaluation noted there was a foreign piece of material measuring 3.00mm^2 on the inside of the syringe.This is out of specification per inspection procedure, which states, "loose or embedded foreign matter shall not exceed an aggregate total of 0.6mm² per tappi dirt estimation chart." although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be defective/ contaminated components from supplier.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "do not use if package is damaged.Warning: 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.Caution: secure tip tightly prior to use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." 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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