SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP CKV 2SS 117-IN 20PK; INTRAVASCULAR ADMINISTRATION SET
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Model Number 2420-0500 |
Device Problems
Material Separation (1562); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown device manufacture date: unknown investigation summary: the customer reported an issue of separation with bd infusion set of material 2420-0500.This complaint was captured using information provided by health (b)(6) medical devices online databases.No photos or samples were provided and without further information, the complaint cannot be verified and the root cause of this failure remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.Investigation conclusion: the customer reported an issue with bd infusion set.This complaint was captured using information provided by health (b)(6) medical devices online databases.No photos or samples were provided and without further information, the complaint cannot be verified and the root cause of this failure remains unknown.
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Event Description
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It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced component separation, and device damage while still considered operable.The following information was provided by the initial reporter: defective component, material separation.
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