Catalog Number 300142 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd syringe 20ml e/t precise, the device experienced leakage.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: are faulty leaking at the base of the syringe.As the rubber doesn't fit correctly.Please inform the company / supplier.Have removed a whole box of the shelf 10 were ¿ tried all the same.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/19/2021.H.6.Investigation: ten representative samples from batch 1049932 were received by our quality team for evaluation.From the samples, no defective or damaged stopper or stopper mis-assembly were observed.A device history record review found no non-conformances associated with this issue during production of the nonreported batch.At the syringe assembly machine, there is sensor installed to detect and reject parts with stopper mis-assembly which is tested daily.The assembly process has a mechanism control to check the stopper leakage.Based on the investigation and dhr reviewed, there is no sensor or vision system abnormality during the production of the received batch, therefore the root cause could not be determined.H3 other text : see h.10.
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Event Description
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It was reported when using the bd syringe 20ml e/t precise, the device experienced leakage.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: are faulty leaking at the base of the syringe.As the rubber doesn¿t fit correctly.Please inform the company / supplier.Have removed a whole box of the shelf 10 were ¿ tried all the same.
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Search Alerts/Recalls
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