Catalog Number 323487 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/20/2019 |
Event Type
malfunction
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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.Date of event: unknown.The date received by manufacturer has been used for this field.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 the lid was found closed on the bd¿ home sharps container before use.The following information was provided by the initial reporter: "consumer reported his sharps container lid was closed right out of the box.".
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Manufacturer Narrative
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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check for difficult/unable to operate (lid closed) due to unknown lot number.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.H3 other text: see section h.10.
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Event Description
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It was reported that the lid was found closed on the bd¿ home sharps container before use.The following information was provided by the initial reporter: "consumer reported his sharps container lid was closed right out of the box.".
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Event Description
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It was reported that the lid was found closed on the bd¿ home sharps container before use.The following information was provided by the initial reporter: "consumer reported his sharps container lid was closed right out of the box.".
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Manufacturer Narrative
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Correction: upon further review of this complaint it has been determined that this incident has been reported in error.The lid of the sharps container was closed out of the box rendering it inoperable and requiring replacement.Therefore this issue is not an mdr reportable malfunction.H3 other text : see section h.10.
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Search Alerts/Recalls
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