Catalog Number 383904 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/21/2022 |
Event Type
malfunction
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Event Description
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It was reported that foreign matter was found in the bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: the nurse found a foreign body at the needle pedicle while preparing the puncture, so it was immediately replaced without causing harm to the patient.
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Manufacturer Narrative
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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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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 1138627.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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.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 foreign matter was found in the bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: the nurse found a foreign body at the needle pedicle while preparing the puncture, so it was immediately replaced without causing harm to the patient.
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Search Alerts/Recalls
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