ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS¿ CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 011-CH2000S-PC |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available for investigation.However, a photograph was provided by the customer and evaluation of the photo is pending.H6: component code description "internal part".
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Event Description
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The complaint event involved a spinning spiros¿ closed male luer, purple cap.Detachment was reported from an internal part of the device.The operator was involved but no consequence was reported.Docetaxel was reportedly involved in the complaint/event.Both the drug and the device were eliminated, and the dilution of the drug was redone.The event led to a delay in the delivery of unspecified therapies.The device did not present any anomalies before it was used.There were no problems or damages to the operator, nor to the patient.
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Manufacturer Narrative
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The complaint of separation on item 011-ch2000s-pc cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history record was reviewed and no non-conformities were found that would have led the reported condition on the complaint.
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Search Alerts/Recalls
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