Catalog Number 305270 |
Device Problem
Unintended Ejection (1234)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/31/2018 |
Event Type
malfunction
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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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Event Description
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It was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage.There was no report of injury or medical intervention.
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Manufacturer Narrative
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Describe event or problem: it was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage.This occurred on 5 separate occasions but the date/time and or patient information is unknown.There was no report of injury or medical intervention.Investigation summary: five sealed packaged integra syringes were received, confirmed to be from batch #6267660 (p/n 305270).They were visually evaluated.No visual defects were found.All 5 syringes were tested for leakage at the hub by aspirating 3.0ml of water and expelling it forcefully through the attached needles then carefully evaluating the needle to syringe connection points.No leakage was observed in any of the samples.The reported defect was not identified in the samples received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
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Event Description
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It was reported with the use of the bd integra¿ syringe with detachable needle there was an issue with leakage.This occurred on 5 separate occasions but the date/time and or patient information is unknown.There was no report of injury or medical intervention.
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Search Alerts/Recalls
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