ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 73" (186 CM) APPX 8.9 ML, 20 DROP ADMIN SET W/15 MICRON FILTER, CLAVE®, ROTATING; STOPCOCK, I.V. SET
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Catalog Number 011-C5060 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
Event Type
malfunction
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Event Description
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The event involved a 73" (186 cm) appx 8.9 ml, 20 drop admin set w/15 micron filter, clave®, rotating luer where the reporter stated that a dirty spot stuck in luer lock during out of package.There was no patient involvement and no patient harm.No additional information involved.
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Manufacturer Narrative
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The device was received for evaluation.The investigation is not yet complete.Distributor information: (b)(4).
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Manufacturer Narrative
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Received one used list #73" (186 cm) appx 8.9 ml, 20 drop admin set w/15 micron filter, clave®, rotating luer with lot #5216782.Received photos showing brown spots on the male luer.The complaint of brown spot on the male luer can be confirmed on the returned device.As received there were multiple brown spots observed on the male luer of the set.The brown spot were observed to be embedded in the wall and not in the fluid path.There brown spots are burnt material embedded in the wall during the molding process.The most probable cause is burnt material embedded in the wall of the male luer during the molding process in salt lake city.While the device fails visual inspection, the embedded material is not in the fluid path, and does not affect the functionality of the device.The device history record (dhr) was reviewed and no non conformities were found that would have led to the reported complaint.
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