Catalog Number 305217 |
Device Problems
Defective Component (2292); Physical Resistance/Sticking (4012)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 the bd¿ oral dispensing syringe had difficult plunger movement while trying to push out medication.The following information was provided by the initial reporter: "can draw - but is tremendous force to get any medication out.Every single one in the box - used to always be a few but so far this whole box is the same way.Got her box in august 29th but she has been reusing other ones from pervious orders since these do not see to be working.".
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Manufacturer Narrative
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Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We appreciate you taking the time to bring this observation to our attention.We regret any inconveniences this incident may have caused you and your facility.See narrative below.
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Event Description
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No additional information was provided.
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Search Alerts/Recalls
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