Model Number 381834 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that 1 bd insyte¿ autoguard¿ shielded iv catheter had foreign matter issues.The following information was provided by the initial reporter : the user facility reported foreign material on the tip of catheter before use.
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 25-jul-2022.H6: investigation summary: bd received a 20 gauge insyte autoguard unit from lot 1230863 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no visible pieces of foreign matter (fm) on the catheter tip.Next, the unit was inspected under a microscope and a piece of translucent fm was present on the needle tip.A piece of the fm was collected and tested using ftir analysis.It was determined that the fm was likely a polypropylene-polyethylene copolymer or a piece of plastic.Therefore, based off the microscopic inspection and testing the engineer was able to verify the reported defect.Unfortunately, the engineer could not determine the exact origin of the fm.The plastic identified was used in the needle cover but could also have been introduced due to environmental factors.The manufacturing facility has been notified of this incident and the findings.
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Event Description
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It was reported that 1 bd insyte¿ autoguard¿ shielded iv catheter had foreign matter issues.The following information was provided by the initial reporter : the user facility reported foreign material on the tip of catheter before use.
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Search Alerts/Recalls
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