Catalog Number 401622 |
Device Problem
Complete Blockage (1094)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/22/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the epidural catheter from bd durasafe¿ tray that the catheter was clogged during use.The following was reported by the initial reporter (translated from chinese): the purchasing teacher reported that when the product was used for the patient, it was found that the front end of the epidural catheter was attached to the wall, resulting in the inability of the liquid to flow out after the catheter was placed.
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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 epidural catheter from bd durasafe¿ tray that the catheter was clogged during use.The following was reported by the initial reporter (translated from chinese): the purchasing teacher reported that when the product was used for the patient, it was found that the front end of the epidural catheter was attached to the wall, resulting in the inability of the liquid to flow out after the catheter was placed.
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Manufacturer Narrative
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Investigation summary: a device history review was conducted for lot number 1312059.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.Additionally a sample was submitted to aid in our investigation.Our engineers noted that the device was returned in an opened packaging unit and displayed a large kink near the tip of the indwelling catheter.The issue has been confirmed.
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Search Alerts/Recalls
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