It was reported by vygon, tidi's distributor in europe: bandage does not hold sufficiently on the skin, very inflammatory picc under tegaderm.Occurred with the piccline "griplock" holding system in the hematology intensive care unit.This problem is not recent but is recurrent.
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Product samples are not available for evaluation.Therefore, this report is based solely on customer-provided information.The customer has been contacted for more information regarding the complaint, but no additional information was provided.The device history record for the complaint lot was reviewed and identified no nonconformances or anomalies that could have contributed to the reported complaint.All reviewed samples passed inspection before release for distribution.Retain samples were reviewed from the reported lot and no issues were identified, all samples passed functional testing.The complaint could not be reproduced.Through additional communication with the importer, they reported that their sales team are well trained and experienced in using the grip-lok.The hospital where the complaint originated normally uses a different securement device, but were provided with an emergency shipment of grip-lok to tide them over until supply chain issues could be resolved.Vygon had reported that they had determined that some of the clinicians were not sufficiently trained by the hospital¿s education staff.The facility has since gone back to using a device with which they are familiar.Currently, there is no evidence that a manufacturing nonconformance contributed to the reported complaint.We will continue to monitor for these types of complaints.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.Manufacturer reference file: (b)(4).
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