Catalog Number 381411 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the bd insyte-n¿ autoguard¿ shielded iv catheter experienced the needle piercing through the needle shield/cap/cover.The following information was provided by the initial reporter: material no: 381411, batch no: 9207656.Product: bd insyte-n autoguard shielded iv catheter.Number of defective product(s): 1.The needle in this iv catheter pierced the cannula shield and was then unable to be used.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/16/2021.H.6.Investigation: our quality engineer inspected the sample submitted for evaluation.Bd received one used device with opened packaging and a 10 ml syringe.Visual inspection of the sample revealed that the needle had speared through the tubing wall, confirming the defect of needle through catheter.This type of defect can occur during the manufacturing process or in the clinical setting.The presences of bodily fluids throughout the catheter and needle indicate that the device was correctly assembled at the time of use.Therefore, the defect most likely originated during use.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 the bd insyte-n¿ autoguard¿ shielded iv catheter experienced the needle piercing through the needle shield/cap/cover.The following information was provided by the initial reporter: material no: 381411, batch no: 9207656.Product: bd insyte-n autoguard shielded iv catheter.Number of defective product(s): 1.The needle in this iv catheter pierced the cannula shield and was then unable to be used.
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Search Alerts/Recalls
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