Catalog Number 381811 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2021 |
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 when using the bd insyte-n¿ autoguard¿ shielded iv catheter, the device experienced the needle retraction failure.The following information was provided by the initial reporter.The customer stated: patient in the emergency room to receive drug therapy with neonatal autoguard catheter # 24, when trying to remove the needle, it did not retracted.The medical device was discarded for being contaminated.The report is made to you due to the techno vigilance program.There was no damage reported.
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Event Description
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It was reported when using the bd insyte-n¿ autoguard¿ shielded iv catheter, the device experienced the needle retraction failure.The following information was provided by the initial reporter.The customer stated: patient in the er to receive drug therapy with neonatal autoguard catheter # 24, when trying to remove the needle, it did not retracted.The medical device was discarded for being contaminated.The report is made to you due to the technovigilance program.There was no damage reported.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 0176393.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, the physical sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h10.
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Search Alerts/Recalls
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