Model Number 381411 |
Device Problem
Material Frayed (1262)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2022 |
Event Type
malfunction
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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 that an unspecified number of bd insyte-n¿ autoguard¿ shielded iv catheters were sheared when retracting the needle.The following information was provided by the initial reporter: "the pediatric ed nurses have experienced multiple instances of the plastic catheter shearing at the ends when the needle retracts.This has caused unnecessary sticks for multiple patients.".
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Manufacturer Narrative
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H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported that an unspecified number of bd insyte-n¿ autoguard¿ shielded iv catheters were sheared when retracting the needle.The following information was provided by the initial reporter: "the pediatric ed nurses have experienced multiple instances of the plastic catheter shearing at the ends when the needle retracts.This has caused unnecessary sticks for multiple patients.".
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Search Alerts/Recalls
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