Catalog Number 305160 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that sharps coll 6gal red small open cap lid was broken.The following information was provided by the initial reporter: the customer reported that the sc lid was broken on arrival.
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Event Description
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It was reported that sharps coll 6gal red small open cap lid was broken.The following information was provided by the initial reporter: the customer reported that the sc lid was broken on arrival.
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Manufacturer Narrative
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H.6.Investigation: no photos or samples were received.Additional attempt to get more information was made, however, the customer confirmed that no additional information was available.The dhr review was not performed due to the lot number was not provided by customer.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken for the same part number throughout the last twelve months.Based on information provided it was not possible to confirm the root cause like a failure mode related to the manufacturing process because there is not enough information like method used to repackage, shipped partial sells using inadequate packaging and controls to storage the remaining product within distributor facility.H3 other text : see h.10.
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Search Alerts/Recalls
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