The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of leaking from the balloon was confirmed as manufacturing related.One 20fr tri-funnel replacement device was returned for investigation.The balloon was not inflated.Residue was observed within the feeding tube.A microscopic examination revealed that the white plug was not located within the distal end of the inflation lumen.An attempt was made to inflate tri-funnel balloon with water, but the infused liquid bypassed the balloon and exited from the distal end of the device.The complaint sample was forwarded to the manufacturing facility for further review.The current process controls were reviewed and the personnel involved in the manufacturing process were notified and retrained.
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