The customer reported that the female end of the ck1001 - mask aerosol ped w/misty & 7ft tbg 50/cs was not able to easily be attached to an oxygen tree, and the flange prevented a few of their compressor units from being used.Staff have been working around this issue by using additional tubing; however, this is leading to waste, which they would prefer to avoid.The patient's impact or harm is currently unknown.
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H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Based on the investigation and since the customer did send photos of the fg ck1001 with lot number 0004250616 for the investigation, we require the physical sample and/or pictures as evidence to perform a better investigation to confirm the reported defect and determine the cause.In addition, the device history record is reviewed as part of the investigation; however, since the lot number was not provided, the review was not possible.Additionally, a sampling was performed by quality personnel on component female u-connector part number 65-4198c (used for the manufacture of fg ck1001) in inventory by dimensionally inspecting the cavity where it is assembled, finding all inspected samples within specifications.Based on the above, the reported defect was not confirmed, and the root cause was not established.
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