It was reported a ultrathane mac-loc locking loop multipurpose drainage catheter was placed and drew in air around the hub when aspirated (medwatch: 1820334-2018-01656).A second device, reported here, was opened and upon aspiration the hub fell off.A third device was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Additional information: although requested, additional event details (date of event, type of drainage procedure, drainage site) are unavailable.Investigation - evaluation: (b)(4).A review of the documentation was 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.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Appropriate measures have been initiated to address this failure mode.We have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.
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