ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/1.2 MICRON FILTER, CLAVE¿, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
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Catalog Number B9041 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A couple of photos were shared by customer, where is observed basically a separation of the male-adaptor from the device, even though some of the photos were blurred the condition of separation is still clear.One (1) used sample list #b9041 was returned for evaluation, as received the component lock male-adaptor was missing from the set, it was confirmed through uv light that the tube didn¿t have enough solvent.The tube was within specification.No mating device was returned and no additional damage or anomaly were observed.Complaint of disconnection / loose connection can be confirmed.The probable cause was due to insufficient solvent applied during manual process assembly in ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
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Event Description
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The incident involved a 14" ext set w/1.2 micron filter, clave¿, clamp, rotating luer on an unknown date.It was reported the customer had a total parenteral nutrition (tpn) extension set become disconnected while in use on a patient.There was patient involvement and unknown patient harm reported.This is the first of four reports.
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Search Alerts/Recalls
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