Catalog Number 383912 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/19/2019 |
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 prior to use it was discovered that the needle was loose with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from (b)(6) to english: before penetration after unwrapped the package it's noticed that needle core and safety shield loosen.Thus unable to penetrate.
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Event Description
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It was reported that prior to use it was discovered that the needle was loose with a bd pegasus¿ safety closed iv catheter system.The following information was provided by the initial reporter, translated from chinese to english: before penetration after unwrapped the package it's noticed that needle core and safety shield loosen.Thus unable to penetrate.
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Manufacturer Narrative
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H.6.Investigation: a device history review was conducted for lot number 9141617.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.Unfortunately a sample could not be obtained for evaluation and testing.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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Search Alerts/Recalls
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