Model Number 309628 |
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 03/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility: (b)(6).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 luer-lok¿ tip syringe was missing scale markings.The following information was provided by the initial reporter: a few bd plastipak syringes 1 ml ll sku without scale.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 26-apr-2022.H.6.Investigation: one sample of a 1ml luer-lock syringe (p/n 309628) was received and evaluated.Through visual inspection no print observed on syringe.The condition observed is non-conforming per product specification.Potential root cause for the missing print defect is associated with the marking process.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.H3 other text : see h.10.
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Event Description
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It was reported that the bd luer-lok¿ tip syringe was missing scale markings.The following information was provided by the initial reporter: a few bd plastipak syringes 1 ml ll sku without scale.
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Search Alerts/Recalls
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