ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 53 CM (21") ADD-ON 150 ML BURETTE SET (CLAVE¿, SHUT-OFF), VENTED CAP; STOPCOCK, I.V. SET
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Catalog Number 011-C7014 |
Device Problems
Contamination (1120); Particulates (1451)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available to be returned for evaluation; however, it has not yet been received.
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Event Description
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The incident involved a 53 cm (21") add-on 150 ml burette set (clave¿, shut-off), vented cap between (b)(6) 2023.The reporter stated that four sets, upon opening, were noted to have discoloration and dark particulate on the shut-off valve within the burette.There was no patient involvement, no patient harm, and no delay in therapy.This is the third of four incidents.
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Manufacturer Narrative
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The discoloration of the 011-c7014 burette shut-off float latex free diaphragm was confirmed on one of the two returned samples.The complaint of visible particulate was not confirmed, just a shut-off float diaphragm which was a dark amber color.Both 011-c7014 burettes were functionally tested and both burette shut-off floats performed as expected even though the latex free diaphragm of one of them was discolored.The probable cause of the latex free diaphragm discoloration is not known but did not affect product function.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer 08-jun-2023.
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