Catalog Number 383904 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd pegasus intravenous catheter the tubing clamp didn't function properly.There was no report of patient impact.The following information was provided by the initial reporter: 6-10 morning, again during intravenous fluids found in patients with indwelling needle clamp in the closed state, the blood flow to the junction, still blood coagulation, cause indwelling needle tube road congestion,pull out the indwelling needle immediately, and replace the indwelling needle with a new one.
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 1354577.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 while using bd pegasus intravenous catheter the tubing clamp didn't function properly.There was no report of patient impact.The following information was provided by the initial reporter: 6-10 morning, again during intravenous fluids found in patients with indwelling needle clamp in the closed state, the blood flow to the junction, still blood coagulation, cause indwelling needle tube road congestion,pull out the indwelling needle immediately, and replace the indwelling needle with a new one.
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Search Alerts/Recalls
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