ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Model Number 12568 |
Device Problem
Air/Gas in Device (4062)
|
Patient Problem
Air Embolism (1697)
|
Event Date 04/01/2022 |
Event Type
malfunction
|
Event Description
|
The event occurred on unspecified date on (b)(6) 2022 involving a microclave® neutral connector where it was reported that the hub of the iv is falling off/apart, and an air embolism was identified on computed tomography (ct) on the peripheral site.There was patient involvement but no patient harm.No additional information was provided.This is the sixth of eight events.
|
|
Manufacturer Narrative
|
Device has been received; however, investigation is still pending.
|
|
Event Description
|
Received additional informational on 21-jun-2022 stating the facility confirmed priming of microclave and luering on tightly.The customer also stated that in the computed tomography (ct) area, when doing biopsy, they use an extension set (item number 12517-01 from icu med) and syringe kit (item number sss-ctp-qft from medrad stellant).They typically connect angicath directly to microclave.The doctor prefers this method as it creates consistent pressure.They also used flush syringe (item number 306546 from bd).
|
|
Manufacturer Narrative
|
Received eighty-two new clave¿ neutral connector with list #12568 and lot #5809423.Thirty-five of the returned samples were randomly selected as if the whole lot population was available to draw from for functional testing.The samples were disconnected, and pressure leak tested.No leaks observed in the activated and inactivated state.There were no disconnections noted.No stick downs observed during multiple activation test.Received 2 photos showing the clave connected attached to a catheter and no damages or anomalies noted.The complaint of separation could not be confirmed or replicated.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Additional information: a5 - ethnicity, a6 - race, b5 - describe event or problem, and d10 - product.
|
|
Search Alerts/Recalls
|
|
|