It was reported that the customer received a spike in complaints from patients related to leaky 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.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 product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
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