Model Number 382534 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2021 |
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 2 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a slow needle retraction.The following information was provided by the initial reporter: " it was reported resistance when pulling out of the actual iv catheter pulling the iv catheter back out of the vein.".
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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 2 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a slow needle retraction.The following information was provided by the initial reporter: " it was reported resistance when pulling out of the actual iv catheter pulling the iv catheter back out of the vein.".
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used un-retracted needle assembly with an opened package.Based on the reported issue of experiencing resistance with the forces between the needle and catheter tubing when removing the needle resulting in the catheter backing out of the vein, this force can be high during retraction due to insufficient lubrication on the needle and improper application including not breaking tip adhesion.Since the returned device has been used, lubrication testing cannot be performed as the original lubrication was affected by use and tests will be inaccurate.We were unable to confirm the reported issue.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
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Event Description
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It was reported that 2 bd insyte¿ autoguard¿ bc shielded iv catheters blood control technology had a slow needle retraction.The following information was provided by the initial reporter: " it was reported resistance when pulling out of the actual iv catheter pulling the iv catheter back out of the vein.".
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Search Alerts/Recalls
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