It was reported that the customer received a spike in complaints from patients related to leaky cadd extension set with male/male luer, 0.2-micron air-eliminating filter, integral anti-siphon valve, and clamp.Customer asked if there was a known defect with this tubing.Patients were asked to return their leaky extension sets to them for further evaluation.Received from accredo a report with malfunction from (b)(6)2023, where 67 patients were affected.About injuries no major issues were reported, some patients mentioned exhibiting pah symptoms.
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Other, other text: no lot number was provided; therefore, a device history record (dhr) review could not be conducted.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.D4: catalog number, udi number, and lot number, and expiration date are unknown; g5: 510k is unknown; h4: device manufacture date is unknown.
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