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Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Pulmonary Hypertension (4460)
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Event Date 01/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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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 pulmonary arterial hypertension symptoms.
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Manufacturer Narrative
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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, lot number, expiration date and udi number are unknown; h4: unknown; g5: unknown.
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Search Alerts/Recalls
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