Catalog Number 302131 |
Device Problems
Partial Blockage (1065); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
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 that the bd¿ luer-slip syringe with needle plunger was difficult to move and medicine leaked from the hub connection.This occurred with 10 separate syringes during use.The following information was provided by the initial reporter: "the plunger doesn't easy to be pushed and pulled.Sometimes, medicine may leak out between hub and syringe during use".
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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 that the bd¿ luer-slip syringe with needle plunger was difficult to move and medicine leaked from the hub connection.This occurred with 10 separate syringes during use.The following information was provided by the initial reporter: "the plunger doesn't easy to be pushed and pulled.Sometimes, medicine may leak out between hub and syringe during use".
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Event Description
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It was reported that the bd¿ luer-slip syringe with needle plunger was difficult to move and medicine leaked from the hub connection.This occurred with 10 separate syringes during use.The following information was provided by the initial reporter: "the plunger doesn't easy to be pushed and pulled.Sometimes, medicine may leak out between hub and syringe during use.".
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Manufacturer Narrative
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H.6.Investigation: eleven samples were received by our quality team for evaluation.One sample was received in open packaging without the syringe barrel and ten representative samples were received in sealed packaging.The representative samples were subjected to plunger breakout and sustaining force testing and the leak test.The samples passed the testing.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
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Search Alerts/Recalls
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