Catalog Number 305219 |
Device Problem
Leak/Splash (1354)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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It was reported that syringe oral 10ml clear caps are falling off.The following information was provided by the initial reporter: material# 305219, lot#0087083.It was reported caps are falling off.Called consumer to follow up with product complaint.Consumer stated the caps are falling off of his oral syringes.Stated either the caps are too big or the syringes are too small.Confirmed demographic information and also provided pharmacy information for replacement.
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Event Description
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It was reported that syringe oral 10ml clear caps are falling off.The following information was provided by the initial reporter: material# 305219, lot#0087083.It was reported caps are falling off.Called consumer to follow up with product complaint.Consumer stated the caps are falling off of his oral syringes.Stated either the caps are too big or the syringes are too small.Confirmed demographic information and also provided pharmacy information for replacement.
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Manufacturer Narrative
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Investigation summary: one loose 10ml oral syringe with tip cap was received and evaluated.No visual defects were observed.Pressure testing of the tip cap was performed.The results indicated the product was within specification.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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