Catalog Number 382533 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 bd insyte¿ autoguard¿ bc shielded iv catheter backed out of the vein while retracting it.The following information was provided by the initial reporter: "needles feels dull and is requiring multiple sticks for access.Iv's are blowing due to force needed to insert.Catheter pops out of the skin when retracting.".
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Manufacturer Narrative
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Investigation results: our quality engineer inspected the representative samples submitted for evaluation.Bd received 56 sealed 20ga x 1.00in.Insyte autoguard bc units from lot number 3096287.A penetration test was performed, and all 56 units passed specifications.Tip adhesion was broken on each unit and retracted to attempt to replicate the reported defect.No defects were discovered during retraction.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in the report.A device history record review showed no non-conformances associated with these issues during the production of these batches.Complaints received for this device and reported condition will continue to be tracked and trended.
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Event Description
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No additional information.
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Search Alerts/Recalls
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