Catalog Number 303450 |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd¿ sharps collector lid would not close.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about the sharps collector's lid not remaining shut.According to the customer's report, the lid is shut but does not remain shut and is soon open.".
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: na.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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Manufacturer Narrative
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H6: investigation summary due to incorrect material number, no batch/lot, or no sample being received, investigation could not be performed and the production records could not be evaluated.A device history review could not be completed as no batch number was provided.This complaint of lid will not shut could not be verified and the root cause remains unknown.
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Event Description
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It was reported that the bd¿ sharps collector lid would not close.The following information was provided by the initial reporter, translated from japanese: "this is a report about the sharps collector's lid not remaining shut.According to the customer's report, the lid is shut but does not remain shut and is soon open.".
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Search Alerts/Recalls
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