ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 03 ML SAFESET¿ RESERVOIR KIT W/SINGLE NEEDLELESS VALVE; CATHETER, CONTINUOUS FLUSH
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Catalog Number 011-46102-55 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation, however, it is not yet received.
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Event Description
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The event involved 03 ml safeset¿ reservoir kit w/single needleless valve in which the customer reported that a fault was noted on night shift.The arterial line became disconnected during patient use.The patient was noted to be arterially bleeding into the bed (less than 10ml).Staff removed the faulty tubing from the patient and opened another arterial line; they noted this 03ml safeset resevoir kit w/single needleless valve to have the same fault.No medication was being used with the product.The product was not seen to be faulty being removed straight out of package.There was patient involvement, with delay in therapy, but no harm was reported as a consequence of this event.This report reflects 1 of the 2 occurrences.
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Manufacturer Narrative
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Device was received 1/10/24 for evaluation.During visual inspection, the 5" pressure tubing was received separated from the female luer.When the end of the tubing was microscopically examined, insufficient adhesive coverage was observed.An image was provided by the customer showing a pressure tubing separation from the female luer.The probable cause of the pressure tubing separated from the female luer had occurred due to insufficient adhesive coverage on the tubing during manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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