Catalog Number 381511 |
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 01/27/2023 |
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 during use with 2 bd insyte¿-n autoguard¿ shielded iv catheter the catheter sheared.Patient had to be stuck several times due to the shearing.The following information was provided by the initial reporter: (1st of 2 occurrences) one of our nicu baby¿s needed an iv.Two nurses were working together to place it.They used this product and the catheter sheared when she tried to put it in.This actually happened three time with the same lot number on three different catheters.I do not think the nurse thought to look at the lot until after the fact but it was all the same lot number: 2146599.
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Manufacturer Narrative
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H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
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Event Description
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It was reported that during use with 2 bd insyte¿-n autoguard¿ shielded iv catheter the catheter sheared.Patient had to be stuck several times due to the shearing.The following information was provided by the initial reporter: (1st of 2 occurrences).One of our nicu baby¿s needed an iv.Two nurses were working together to place it.They used this product and the catheter sheared when she tried to put it in.This actually happened three time with the same lot number on three different catheters.I do not think the nurse thought to look at the lot until after the fact but it was all the same lot number, 2146599.
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Search Alerts/Recalls
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