Catalog Number 380510 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that drug leaked from the bd q-syte¿ luer access split-septum stand-alone device, bns during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "drug leaked.No info where the drug leaked from.".
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Event Description
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It was reported that drug leaked from the bd q-syte¿ luer access split-septum stand-alone device, bns during use.The following information was provided by the initial reporter, translated from japanese to english: "drug leaked.No info where the drug leaked from.".
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Manufacturer Narrative
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Additional information: multiple lot numbers: there were multiple lot numbers possibly involved.The information for each lot number is as follows: d.4.Medical device lot #: 8212687.D.4.Medical device expiration date: 8/31/2023.H.4.Device manufacture date: 7/31/2018.D.4.Medical device lot #: 8269826.D.4.Medical device expiration date: 10/31/2023.H.4.Device manufacture date: 9/26/2018.H.6.Investigation summary: a device history review was conducted for lot number 8212687 & 8269826.Our records show that this is the only instance of this issue occurring in either production batch.According to the sampling plan applied for product performance, these lots were accepted and released without defects being noted during the final assembly or visual inspections.Evaluation of the submitted device was unable to identify any abnormalities that could have contributed to the leakage.Based on our review, the root cause for this complaint could not be determined at the conclusion of our review.
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Search Alerts/Recalls
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