Catalog Number 383323 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that 1 bd saf-t-intima¿ iv catheter safety system had safety shield activation failure issues.The following information was provided by the initial reporter : the customer reported that the needle safety mechanism did not engage and the stylet got stuck while the clinician was trying to pull it out.
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 1 bd saf-t-intima¿ iv catheter safety system had safety shield activation failure issues.The following information was provided by the initial reporter : the customer reported that the needle safety mechanism did not engage and the stylet got stuck while the clinician was trying to pull it out.
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Manufacturer Narrative
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H.6.Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 1287176.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.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 h.10.
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Search Alerts/Recalls
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