ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
|
Back to Search Results |
|
Model Number 42800-39 |
Device Problems
Disconnection (1171); Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/01/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned for evaluation; however, testing has not yet been completed.
|
|
Event Description
|
The event occurred on an unspecified date and involved a transpac¿ it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve.The reporter stated that a picu/nicu experienced a disconnect of the intravenous (iv) administration extension set at the bonding point on their transpac it transducer.There was no patient involvement or patient harm reported.
|
|
Manufacturer Narrative
|
The reported complaint of separation was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the pvc tubing was found separated from the transducer luer pocket.The pvc tubing was observed to be tacky.The probable cause of the pvc tubing being tacky was due to the tubing not being fully cured during assembly.
|
|
Search Alerts/Recalls
|
|
|