ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 25 CM (10") PUR YELLOW SMALLBORE EXT SET, 6-PORT NANOCLAVE¿ MANIFOLD W/CHECK VAL; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Catalog Number 011-AM6136 |
Device Problem
Air/Gas in Device (4062)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/30/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is expected to be returned for evaluation, however, it has not yet been returned.Initial reporter phone extension- (b)(6).
|
|
Event Description
|
The event involved a 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer.The customer reported that the device does not connect to a catheter (it rotates, but does not connect).Air bubbles were observed and there was a delay in therapy as the device had to be replaced.The event was observed when installing the device; there was patient involvement, no blood loss and no harm reported as a consequence of this event.
|
|
Manufacturer Narrative
|
One used 25 cm (10") pur yellow smallbore ext set, 6-port nanoclave¿ manifold w/check valve, nanoclave¿, 4-way nanoclave¿ stopcock (red ring), rotating luer were returned for evaluation.A photo was returned identifying the spin luer of the nanoclave stopcock as being the focus of the complaint about disconnecting from a catheter.No mating device catheter was returned to evaluate with the 011-am6136 extension set.There was no visible damage or anomalies observed with the returned assembly.The used extension set was evaluated and functionally measured and tested and the male luer connection was iso design compliant and did not result in leakage or air ingress during testing and there was no propensity to disconnect from the mating female luer during testing.Without return of the mating device catheter the complaint was unable to be replicated or confirmed.A device history review could not be conducted because no lot number(s) was/were identified.Additional information d9 - date device received 2/21/23.
|
|
Search Alerts/Recalls
|
|
|