ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number D1000 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Blood Loss (2597)
|
Event Date 08/15/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been received for evaluation.Investigation is pending.
|
|
Event Description
|
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.This report captures the third of three devices.
|
|
Manufacturer Narrative
|
H10: received one used list# d1000, tego¿ connector.Lot# 4743519.The used d1000 tego assembly had seal tearing damage near the top surface of the seal.During functional testing the used d1000 tego assembly was confirmed to leak.The used d1000 tego assembly did not leak even though it did have some seal tearing damage.No mating devices were returned to evaluate with the used d1000 tego assembly.A device history review (dhr) lot# 4743519 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|