Catalog Number 383083 |
Device Problems
Free or Unrestricted Flow (2945); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/19/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd intima-ii¿ closed iv catheter system there was a loose tubing clamp.The following information was provided by the initial reporter.The customer stated: "when the nurse placed a needle for the patient, she found the adjustment switch was not fully clamped.".
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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 0357733.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 0357733.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 when using the bd intima-ii¿ closed iv catheter system there was a loose tubing clamp.The following information was provided by the initial reporter.The customer stated: "when the nurse placed a needle for the patient, she found the adjustment switch was not fully clamped.".
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Search Alerts/Recalls
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