Model Number MZ5307 |
Device Problems
Break (1069); Failure to Disconnect (2541); Material Integrity Problem (2978)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/01/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
|
|
Event Description
|
The customer reported on9wt hematology/oncology , a rn was heparin locking a patient who was to be discharged home, and they were unable to disconnect the bifuse from the white lumen.The "luerlock" end of the bifuse was stripped and the hub was not able to be turned in order to dislodge from the cap.The end of the product broke off into the cap and the rn had to compete a cap change early, even though it had just been changed the day prior.There was no patient harm.
|
|
Event Description
|
The customer reported on9wt hematology/oncology, a rn was heparin locking a patient who was to be discharged home, and they were unable to disconnect the bifuse from the white lumen.The "luerlock" end of the bifuse was stripped and the hub was not able to be turned in order to dislodge from the cap.The end of the product broke off into the cap and the rn had to compete a cap change early, even though it had just been changed the day prior.There was no patient harm.
|
|
Manufacturer Narrative
|
The customer¿s report of an inability to disconnect the bifuse from the white lumen was not confirmed.The customer¿s report that the product broke and was stripped was confirmed.Visual inspection showed that the male spin collar on the extension set had a crack running parallel to the direction of the flow.Further inspection of the damaged component under magnification showed that the ridges on the male luer were stripped.The maxzero valve that was connected to the extension set was successfully disconnected from the extension set.The root cause of the product breakage is excessive force being applied to the product when attempting to disconnect and/or over-tightening when the mating components were connected.
|
|
Event Description
|
The customer reported on9wt hematology/oncology , a rn was heparin locking a patient who was to be discharged home, and they were unable to disconnect the bifuse from the white lumen.The "luerlock" end of the bifuse was stripped and the hub was not able to be turned in order to dislodge from the cap.The end of the product broke off into the cap and the rn had to compete a cap change early, even though it had just been changed the day prior.There was no patient harm.
|
|
Manufacturer Narrative
|
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
|
|
Search Alerts/Recalls
|