Catalog Number 383083 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd intima-ii¿ closed iv catheter system had defective tubing.The following information was provided by the initial reporter: "when using the closed indwelling needle, cracks were found in the indwelling needle tube".
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Manufacturer Narrative
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H6: investigation summary: a device history review was conducted for lot number 1020961.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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Event Description
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It was reported that bd intima-ii¿ closed iv catheter system had defective tubing.The following information was provided by the initial reporter: "when using the closed indwelling needle, cracks were found in the indwelling needle tube".
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Search Alerts/Recalls
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