Catalog Number 383033 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked at the connection between the adapter and tubing during use.The following information was provided by the initial reporter, translated from chinese: "before using the needle for venipuncture on (b)(6) 2022.(b)(6), the infusion set was connected to the indwelling needle to drain the air in the indwelling needle.Fluid leakage was found at the connection between the extension tube and the two forking tubes.The indwelling needle was replaced immediately without any adverse consequences for the child.".
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Manufacturer Narrative
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Investigation summary: in response to the event reported, a device history review was conducted for lot number 1230658.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Manufacturer Narrative
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Investigation summary: in response to the event reported, a device history review was conducted for lot number 1230658.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system leaked at the connection between the adapter and tubing during use.The following information was provided by the initial reporter, translated from chinese: "before using the needle for venipuncture on (b)(6) 2022.(b)(6), the infusion set was connected to the indwelling needle to drain the air in the indwelling needle.Fluid leakage was found at the connection between the extension tube and the two forking tubes.The indwelling needle was replaced immediately without any adverse consequences for the child.".
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Search Alerts/Recalls
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