OAKDALE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET; WARMER, THERMAL, INFUSION FLUID
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Model Number L-70 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that while infusing medical fluid into the patient through the product, leakage from the connector was observed.No patient injury was reported.
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Manufacturer Narrative
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Month and year of event have been provided, day is unknown.Lot number and expiration date is unknown, no product 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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Manufacturer Narrative
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Other text: h6 health impact and conclusion codes: updated.Device evaluation: one device and two photos were returned for investigation.Visual inspection showed the proximal end female luer connecter to be cracked.During functional testing, the reported failure mode, leak, was confirmed.Based on the sample returned by the customer it was not possible to replicate the failure or confirmed as manufacturing process caused.After reviewing the mitigations that are performed during the manufacturing process to detect leak, the root cause is that the female luer connector became damaged after the product left manufacturing facilities.No lot number was provided therefor no device history review (dhr) could be completed.No corrective actions taken., corrected data: d3.
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