The event involved a tego connector that the customer reported blood leaking out of the cap during treatment.The rn noted there was no tear/crack evident with visual inspection, however, it was noted that septum was broken/torn when the rn tried to attach blue tube and flushed the tego cap during investigation.The customer stated it was not detected prior to use.There was 10 ml of blood loss, no property damage, and a medical, or surgical intervention was required.The medical intervention required was the patient requiring blood cultures, and initiation of iv antibiotics due to possible line contamination, and the patient also required hospitalization for monitoring.The current patient status was returned to baseline after the incident.It was also mentioned that the device was replaced with no further problems encountered.There was patient involvement, but no serious injury, or death.
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H10: received: one (1) used list# d1000, tego¿ connector.Lot# 4052480.-->one (1) used connector, unknown manufacturer.A used d1000 tego connector was returned connected at the male luer end to an unidentified female luer adapter.There were no visible damage or anomalies observed with the d1000 tego connector or mating device.Subsequent functional testing showed the d1000 tego connector (with mating device) to meet functional leak expectations outlined in the product performance specification.The complaint of leakage was unable to be confirmed.A device history review (dhr) lot# 4052480 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
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