Catalog Number 383911 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 that the bd pegasus yel 24ga x 0.75in prn came off.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2022 while flushing the patient, the prn that had been tightened suddenly came off.After sterilizing the indwelling needle, replace 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 1019976.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 pegasus yel 24ga x 0.75in prn came off.The following information was provided by the initial reporter, translated from chinese to english: 2022-10-23 while flushing the patient, the prn that had been tightened suddenly came off.After sterilizing the indwelling needle, replace with a new one.
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Search Alerts/Recalls
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