Estimated date of event.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.It is possible that the device(s) was not fully connected resulting in the reported loose connection and the reported leak; however as the device was not returned for analysis, this cannot be confirmed.In addition, as the device was not returned for analysis a conclusive cause for the reported mechanical problem (difficulty locking/unlocking) cannot be determined.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported as a general comment that the indeflator from the priority pak does not connect properly, or has an air leak of some kind.When the indeflator is attached to the balloon and negative is pulled, it fills completely full of air and loses it's suction.There have also been instances of difficulty locking/unlocking.Another indeflator was used to successfully complete the procedire.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported difficulties appear to be a potential product quality issue.On feb 25th, 2022 abbott vascular decided to initiate a voluntary field action.The product associated with this complaint is potentially from the impacted population as the lot number is unknown.Abbott vascular submitted medwatch # 2024168-2022-01831 on march 4, 2022 with notification of the voluntary recall in h7, (remedial action initiated).Corrective action has been initiated per site operating procedures.Field safety corrective action is required for specific lots of 20/30 and plus 30 indeflators and associated priority packs: 20/30 priority pack with copliot, 20/30 priority pack, priority pack 20/30 w/115 rhv, ppak 20/30 with rhv, plus 30, ppakplus30, ppakplus30 w/115 rhv.The product will continue to be trended.This action is being taken due to an increase in the complaint trend for reported leak/splash and loose or intermittent connection.20/30 indeflators are at an increased risk of leaking due to a gap in the hose snap fitting.Stopcocks are at an increased risk of leaking due to a higher tendency for loose connections when not connected properly.Out of an abundance of caution, complaints with the lot number listed as ¿unknown¿ and which are included within the bracketed timeframe for the same reported issues, are being included in the scope.H6: investigation findings code 213 removed h6: investigation conclusions code 67 removed.
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