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According to the customer, the product "seems to have substantially less adhesive properties to the former product," and "when a patient would reposition themselves in bed, the tape would prematurely lift off of patient¿s skin, exposing the drain/skin site, ultimately leading to the drain working its way completely out of the patient, prior to our drain removal criteria"; the patients were monitored for postoperative complications and no additional follow-up care or new drain placement was needed.The supplier was notified of the issue for investigation, and the vendor/manufacturer reviewed any potential cause of defect of dhr and batch record, inspection record, manufacturing, raw material and equipment calibration and preventive maintenance, employee training, and retain sample, which all met the specification as required.After conducting the investigation, the issue reported in the complaint regarding the "lacks adhesive" could not be confirmed with sample received for investigation.The cause was updated to "cannot determine cause w/received sample," and a review of the complaint information as well as the results of the investigation indicate no need for further action at this time.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
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