A review of the photographs provided by the user facility indicate evidence of potential residual adhesive in the tubing of the 3-spike disposable set.However, the photographs are not detailed enough to determine the actual condition of the tubing.Belmont medical technologies requested the lot number of the set, as well as return of the set for investigation.The distributor subsequently confirmed that the lot number of the product in question is unknown and that the product is not available to be returned to belmont medical technologies for review.A review of a specific library/retain sample and batch record information is not possible at this time, as the lot number of the item involved has not been provided.A review was conducted to determine which lot numbers have been shipped to the distributor and could therefore potentially represent the product with which the incident occurred, and the batch records and retain samples for those lots were reviewed.All 3-spike sets are 100% leak tested and 100% visually inspected during the manufacturing process.No manufacturing issues were noted in review of the batch records, and additionally, no defects were noted upon review of the retain samples.A review of complaints for the past three years indicates that this was an isolated incident.It was reported that there was no harm to the patient.We will continue to monitor and trend similar reports of this nature and take further action if required.
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