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 05/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturing location for this product is flextronics.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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that unspecified bd¿ sharps container was received with broken lids.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported by the facility representative that they have received broken lids.
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Event Description
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It was reported that unspecified bd¿ sharps container was received with broken lids.This occurred on 12 occasions.The following information was provided by the initial reporter: it was reported by the facility representative that they have received broken lids.
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Manufacturer Narrative
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H6: investigation summary: the customer provided 12 samples with the complaint of broken lids.The sharps containers were received without any lids so the complaint was investigated by the supplier as it was received.According to the dhr review process, the result showed there were no issues reported like lid broken/damaged during the manufacturing process of the lot number 0303954 reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like lid broken/damaged for the same part number throughout the last twelve months.The supplier investigated this complaint as a missing lids issue due to what was received and were unable to determine root cause.H3 other text : see h10.
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Search Alerts/Recalls
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