Catalog Number 383033 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/06/2022 |
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 intima-ii closed iv catheter system was loose.The following information was provided by the initial reporter, translated from (b)(6) to english.When the puncture was completed, it was found that the heparin cap was loose, and the heparin cap was not changed by forceful twisting, and a new spare single disposable heparin cap was immediately replaced.
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system was loose.The following information was provided by the initial reporter, translated from chinese to english: when the puncture was completed, it was found that the heparin cap was loose, and the heparin cap was not changed by forceful twisting, and a new spare single disposable heparin cap was immediately replaced.
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Manufacturer Narrative
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H6: investigation summary a device history review was conducted for lot number 2137534.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.H3 other text : see h10.
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Search Alerts/Recalls
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