Catalog Number 383019 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd intima ii¿ iv catheter prn adapter experienced damaged packaging where the sterility was compromised.The following information was provided by the initial reporter: nurse used a closed intravenous indwelling needle for the patient's infusion treatment.When she took it out, she found that the outer packaging was damaged, which would cause contamination and made it unusable.Immediately replaced the indwelling needle with the same batch number, and successfully completed the infusion therapy.
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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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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 2199562.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.
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Event Description
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It was reported that the bd intima ii¿ iv catheter prn adapter experienced damaged packaging where the sterility was compromised.The following information was provided by the initial reporter: nurse used a closed intravenous indwelling needle for the patient's infusion treatment.When she took it out, she found that the outer packaging was damaged, which would cause contamination and made it unusable.Immediately replaced the indwelling needle with the same batch number, and successfully completed the infusion therapy.
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Search Alerts/Recalls
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