ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.33ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 3 CLAMPS,; STOPCOCK, I.V. SET
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Model Number 011-MC3316 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problems
Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that the distal luer connection of a braun device disconnected from the microclave, which was connected to the patient and administering paclitaxel and physiological serum.Due to the disconnection the drug spilled on the floor, on the patient's chair and on the patient.An infusomat tree, from b.Braun, was used with the product.The event occurred during patient use, however, there was no delay in therapy, no adverse event and no one was harmed as a result of this event.
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Manufacturer Narrative
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A sister device is available to be returned for evaluation; however, it has not yet been received.
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Manufacturer Narrative
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The complaint of leakage could not be confirmed or replicated on the returned new one (1) new.List #011-mc3316, 6" (15cm) appx 0.33ml, smallbore bifuse ext set w/2 microclave¿ clear, 3 clamps, rotating luer.The returned new device and mating device were leak tested per product specification.There were no leaks or disconnections observed.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: d9 - product received 6/30/2022.
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Search Alerts/Recalls
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