Catalog Number 304086 |
Device Problems
Entrapment of Device (1212); Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that a syringe 10cc s/t wos sterile water bns had plastic debris from the plunger that was found stuck or trapped in between the plunger and inner tip/wall of the barrel.The customer believes this caused a void or channel where water leaked post manufacturing.
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Event Description
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It was reported that a syringe 10cc s/t wos sterile water bns had plastic debris from the plunger that was found stuck or trapped in between the plunger and inner tip/wall of the barrel.The customer believes this caused a void or channel where water leaked post manufacturing.
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Manufacturer Narrative
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Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.The reported issue was previously investigated.It was concluded that the damage found in the barrel was caused due to improper setup of the silicone gun used to spray medical grade silicone inside the barrel.If the silicone gun is setup loose, it could contact and damage the barrel during processing.Situational analysis (b)(4) opened to evaluate the foreign matter issue associated with all complaints received so far and capa: 768379 was also initiated.
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Search Alerts/Recalls
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