Catalog Number 305218 |
Device Problem
Volume Accuracy Problem (1675)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2021 |
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.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe oral 5ml clear had scale marking issues.The following information was provided by the initial reporter: complaint from (b)(6).The customer complained that the scale can be erased by hand easily.
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Event Description
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It was reported that syringe oral 5ml clear haad scale marking issues.The following information was provided by the initial reporter: complaint from macau.The customer complained that the scale can be erased by hand easily.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/5/2021.H.6.Investigation: two photos and one loose 5ml syringe with white tip cap attached was received and evaluated.It was observed there was no visible scale markings, only a few small ink marks in the middle and bottom of the barrel.Based on the verbatim, the reported defect could not be confirmed to originate from the manufacturing site.It was unclear what conditions the syringe was subjected to during the print removal.Potential root cause for the missing print defect could not be defined.Physical unused samples from the same batch are necessary for scale permanency testing.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Search Alerts/Recalls
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