Model Number 305489 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd¿ sharps collector hinge broke off during use.The following information was provided by the initial reporter: "call from an ems customer stating that during an emergency trip the one-piece sharps container.Broke.She states that the hinge that keeps the lid closed broke off at some point and she is not sure how.She states "i am sure it is something on our end, nothing to do with the product."".
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is premium plastic solutions.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
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Manufacturer Narrative
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H6: investigation summary due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.A device history review could not be completed as no batch number was provided.
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Event Description
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It was reported that the bd¿ sharps collector hinge broke off during use.The following information was provided by the initial reporter: "call from an ems customer stating that during an emergency trip the one-piece sharps container.Broke.She states that the hinge that keeps the lid closed broke off at some point and she is not sure how.She states "i am sure it is something on our end, nothing to do with the product."".
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Search Alerts/Recalls
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