It was reported two cook spectrum minocycline/rifampin impregnated five lumen central venous catheters presented a fracture and reflux between medications and liquids used.The first device, subject of this report, was used from (b)(6) 2017.The second device, reported on medwatch 1820334-2018-02597, was used from (b)(6) 2017.Additional information with regards to the patient and event has been requested but not provided by the customer.As reported, the patient did not experience any additional adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: event description: additional information was received on (b)(6) 2018 which detailed there was one patient involved in this event.A third catheter was required to be placed due to the fracture of the second device.Although requested, additional information regarding patient demographics, medical history, additional event details, and patient outcome have not been provided.Investigation - evaluation.A review of the complaint history, drawings, device history record, documentation, manufacturing instructions, specifications, and quality control was conducted during the investigation.A physical examination of the device could not be performed since no product was returned.A representative device from the same lot could not be acquired for evaluation.No photos were provided by the customer.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows two nonconforming events that could contribute to this failure mode.; however, these were scrapped and not released for distribution.A complaint history search revealed one other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be established.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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