ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Model Number B33973 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/08/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been received for evaluation, however, investigation is not yet complete.
|
|
Event Description
|
The event involved a 14" (36 cm) appx 3.6 ml, transfer set w/4 clave, 2 tri-connectors, back check valve, clamp (blue), vented capwhich was reported to have leaked during chemotherapy infusion on a patient.The reporter stated that one of the connectors just pops up, loose and was not connecting and a leak was noted.It was not reported whether or not there was unprotected exposure to the chemotherapy.No harm was reported as a consequence of this event.
|
|
Manufacturer Narrative
|
One used 4" (36 cm) appx 3.6 ml, transfer set w/4 clave¿, 2 tri-connectors, back check valve, clamp (blue), vented cap was received for evaluation.No visual anomalies were observed as received.The complaint of leakage can be confirmed on the returned unit.The set was leak tested pre product specification.There was a leak observed from one of the y-clave from in-between the adapter and the semi rigid bonding pocket.Each of the microclave/adapters on the used sets were tested for bond integrity.The y-clave that leaked separated below specification.The separated adapter was examined.There appeared to be solvent observed on the adapter.However, the bonding pocket appeared to only have solvent on one side.The probable cause of the leakage and separation observed is due to insufficient solvent coverage applied during manual assembly at the manufacturing site.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|