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 08/08/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter e-mail: unknown.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 prn on the bd intima-ii¿ closed iv catheter system was loose and fell off during use.The following information was provided by the initial reporter, translated from chinese: "at 10:10 on (b)(6) 2022, the indwelling needle on the back of the right hand was used for infusion.After the infusion was completed, the tube was sealed, and the patient rested in bed at night.The next day, the responsible nurse found that the prn of the indwelling needle had fell off, and the rest was intact.".
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 2053259.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.
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Event Description
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It was reported that the prn on the bd intima-ii¿ closed iv catheter system was loose and fell off during use.The following information was provided by the initial reporter, translated from chinese: "at 10:10 on (b)(6) 2022.8, the indwelling needle on the back of the right hand was used for infusion.After the infusion was completed, the tube was sealed, and the patient rested in bed at night.The next day, the responsible nurse found that the prn of the indwelling needle had fell off, and the rest was intact.".
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Search Alerts/Recalls
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