It was reported by the customer that while changing the dressing on a picc line where biopatch was used, the top, blue part of the biopatch sticks too much to the dressing and starts to pull out the picc line.The picc line did not come fully out and there was no consequence to the patient.The customer had to use two nurses to change the dressing.
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Integra has completed their internal investigation on december 18, 2017.Results: dhr review; no lot number was provided, thus no dhr review was possible.Complaints history; from november 2015 to november 2017, a total of six (6) complaints related to interaction with the picc line for biopatch product family.(b)(4).Conclusion: given that no return samples will be received and no photos were sent as part of the complaint information, the reported incident could not be confirmed.
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