Catalog Number 300865 |
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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Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd plastipak¿ concentric luer lock syringe there was leakage; the plunger rod was broken/damaged.The following information was provided by the initial reporter.The customer stated: "the plunger broke during the preparation of a syringe (the saline leaked out of the syringe onto the plunger).".
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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: 8/27/2021.H.6.Investigation: one sample and photo received for investigation, upon visual inspection no defects can be observed.Barrel do not present any damage that could have deformed their shape.The stopper is correctly assembled, when the syringe is disassembled the plunger does not show any defect.Further testing was conducted, no sign of leakage occurred.A device history review was performed for lot 2105104, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h.10.
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Event Description
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It was reported when using the bd plastipak¿ concentric luer lock syringe there was leakage; the plunger rod was broken/damaged.The following information was provided by the initial reporter.The customer stated: "the plunger broke during the preparation of a syringe (the saline leaked out of the syringe onto the plunger).".
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Search Alerts/Recalls
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