Model Number 10012241-0500 |
Device Problems
Material Fragmentation (1261); Material Integrity Problem (2978)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient age and dob requested but not provided.
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Event Description
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It was reported that the texium was unable to be attached to the patient.The texium would not thread appropriately and there were "shavings" of the texium still attached.The texium was replaced with a new texium which attached to the patient without difficulty.
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Event Description
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It was reported that the texium was unable to be attached to the patient.The texium would not thread appropriately and there were "shavings" of the texium still attached.The texium was replaced with a new texium which attached to the patient without difficulty.The customer later stated that there were no adverse effects caused to the patient from the event.
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Manufacturer Narrative
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Additional information; h.6.(patient code) the customer¿s report that the texium was unable to be attached was confirmed.Visual inspection under magnification observed some of the threads within the male luer end were not properly molded to the interior wall of the luer.The texium connector was visually inspected for cracks, deformations, or misassemblies.No other obvious issues or damages were observed.Functional testing confirmed leaking at the unsecured connection between the lab set and received texium connector due to the observed defective texium male luer thread molding.The root cause of the leak was due to a molding error condition during the texium valve¿s manufacturing process.This was identified as an isolated event and the manufacturing teams notified.This reported event will continue to be monitored through our tracking and trending processes.
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Search Alerts/Recalls
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