Catalog Number 300460 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2023 |
Event Type
malfunction
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Event Description
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It was reported that 50 bd¿ sharps collectors each from lots 2208001 and 2306002 had issues with the lids not staying closed.The following information was provided by the initial reporter: "lids do not stay closed.At the slightest pressure of the container the lid opens.The nurses move around with her containers full of dirty needles.".
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is flextronics.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed, and the franklin lakes fda registration number has been used for the manufacture report number.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2208001.Medical device expiration date: na.Device manufacture date: 04-aug-2022.Medical device lot #: 2306002.Medical device expiration date: na.Device manufacture date: 09-nov-2022.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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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer.It was reported by the customer that lids do not stay closed could not be verified due to the product not being returned for failure investigation.The lids should be properly installed and remain latched if used as intended.Based upon the information provided, it seems the product was not being used as intended.A device history review was conducted for lot numbers 2208001 and 2306002.
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Event Description
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It was reported that 50 bd¿ sharps collectors each from lots 2208001 and 2306002 had issues with the lids not staying closed.The following information was provided by the initial reporter: "lids do not stay closed.At the slightest pressure of the container the lid opens.The nurses move around with her containers full of dirty needles.".
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Search Alerts/Recalls
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