Model Number 381237 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/18/2020 |
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.(b)(4).
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Event Description
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It was reported that foreign matter was found on the bd insyte¿ peripheral venous catheter hub before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the nurse unwrapped the package and took out the product, she could see a small black spot on the hilt of the hub".
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Event Description
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It was reported that foreign matter was found on the bd insyte¿ peripheral venous catheter hub before use.The following information was provided by the initial reporter, translated from chinese to english: "when the nurse unwrapped the package and took out the product, she could see a small black spot on the hilt of the hub".
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Manufacturer Narrative
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H6: investigation summary a device history review was conducted for lot number 9298167.Our records show that this is the only instance of foreign matter 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 affected device is required for a more in depth analysis of the issue.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.See h.10.
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Search Alerts/Recalls
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