Catalog Number 383078 |
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 10/07/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd discardit¿ ii 10 ml syringe there was foreign matter on the device needle and damaged or open unit package where sterility was compromised.The foreign matter event occurred 19 times.The damaged packaging event occurred 19 times.The following information was provided by the initial reporter.The customer stated: "when opening the device, the outer package of the indwelling needle was damaged and there was water vapor in the extension tube.".
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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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Event Description
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It was reported when using the bd discardit¿ ii 10 ml syringe there was foreign matter on the device needle and damaged or open unit package where sterility was compromised.The foreign matter event occurred 19 times.The damaged packaging event occurred 19 times.The following information was provided by the initial reporter.The customer stated: "when opening the device, the outer package of the indwelling needle was damaged and there was water vapor in the extension tube.".
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 1111427.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.H3 other text: see h10.
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Search Alerts/Recalls
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