ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Catalog Number B33895 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/24/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned for evaluation; however, testing has not yet been completed.
|
|
Event Description
|
It was reported that a 107" (272 cm) transfer set w/dual check valve, microclave®, luer lock experienced a break.There was a breakage of the hard plastic portion of the microclave.The medication involved is not available at this time.There was no patient harm reported.This is the first of two events.
|
|
Manufacturer Narrative
|
Three (3) new and two (2) used samples list #b33895 were returned for evaluation.One of the used samples has a spiro connection.As received the tips of both used blue microclaves were observed to be broken and some beach marks and crazing marks suggesting environmental stress during use were observed.No damage on the new samples was confirmed.No mating device was returned for evaluation.Complaints of cracks can be confirmed based on the physical sample evaluation.The probable cause is typically due to environmental stress during use.A device history review (dhr) was conducted and no relevant commodities, discrepancies, or anomalies were found that might lead to the condition reported by the customer.
|
|
Search Alerts/Recalls
|
|
|