Model Number 309604 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 six syringe 10ml ll had a damaged barrels.The following information was provided by the initial reporter: "6 syringes from this lot had small pin hole in barrel, all in the same spot.".
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Event Description
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It was reported six syringe 10ml ll had a damaged barrels.The following information was provided by the initial reporter: "6 syringes from this lot had small pin hole in barrel, all in the same spot".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-28.Investigation summary: three 10ml syringes received for investigation, samples were visually inspected.On the first syringe there was a hole observed between lines 4 and 5.The second syringe, a small crack is observed between lines 3 and 4.No defects or issues observed on the third syringe.Functional testing was performed, leakage was observed on the first and second sample.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.H3 other text : see h10.
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Search Alerts/Recalls
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