As reported, during an unknown procedure, a three-way plastic stopcock leaked as the user was mixing lipiodol and an unknown chemotherapeutic agent.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence. according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Initial report: as reported, during an unknown procedure, a three-way plastic stopcock leaked as the user was mixing lipiodol and an unknown chemotherapeutic agent.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation.Reviews of the complaint history, device history record, drawing, manufacturer¿s instructions, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.The information available provides objective evidence to support that the device was made to specifications.Cook has concluded that the findings from a previously completed root cause investigation aligns with the conclusion of this complaint.The stopcock stems molded of nylon 6 have the potential to absorb moisture, resulting in an increase in diameter and raising the potential for cracking of the stopcock body, which likely contributed to this incident.Per the quality engineering risk assessment no further action is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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