Catalog Number 309574 |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that there is a hole in the needle hub of a bd plastipak¿ luer-lok¿ syringe with bd precisionglide¿ needle.No patient impact reported.The following information was provided by the initial reporter: there is a hole in the needle hub.
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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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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: 01-aug-2022 h6: investigation summary one sample and four photos were provided to our quality team for investigation.Through visual inspection, it was observed that needle hub has an air bubble and a short shot.It could be possible that a process variation occurred while molding process.A verification of the molding process was performed.The settings were correct, and the flow of products was good.A device history record review was completed for provided lot number 1300750.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.
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Event Description
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It was reported that there is a hole in the needle hub of a bd plastipak¿ luer-lok¿ syringe with bd precisionglide¿ needle.No patient impact reported.The following information was provided by the initial reporter: there is a hole in the needle hub.
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Search Alerts/Recalls
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