Other, other text: b3: date of event, d4: lot number, expiration date, udi number and h4: device manufacture date is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.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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It was reported that there was a crack in the female luer part of the blue filter.The rn had done a routine line change for lipids at around 0900.There had been no over-tightening or any other manipulation of the line or tubing throughout the day.In the evening, it was discovered blood backing up in the line and subsequently noted lipids leaking, at which point the crack was discovered.Adverse patient effects are unknown.
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