ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 011-MC33094 |
Device Problem
No Flow (2991)
|
Patient Problem
Pain (1994)
|
Event Date 10/28/2023 |
Event Type
malfunction
|
Event Description
|
The event involved a 15 cm (6") smallbore ext set w/microclave® clear, clamp, rotating luer.The customer stated after the smallbore extension set was placed, many nurses noticed a strong abnormal resistance when injecting contrast products.A higher flow rate higher than 3ml/sec was needed.The customer decided to place another smallbore extension of the same reference, but the problem persists.They tested the access without the anti-return valve, and at that moment, no more resistance problem.The department had to put back a venous access to the patient causing a new intrusion.The status of the product at the time of the event is during infusion.Clinical consequences to the patient was physical pain.No defect on the product was seen before use.There was patient involvement and delay in therapy, however no report of patient harm.This captures the second of two occurrences.
|
|
Manufacturer Narrative
|
No product samples, videos, or photographs were provided for investigation.The device history review (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.E1 initial reporter address: (b)(6).
|
|
Search Alerts/Recalls
|
|
|