Catalog Number 305642 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd descartex¿ ii sharps collector was shipped without a lid.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "1.Lot: 1273459 - item came in the shipping box without the lid.1 unit.".
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.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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The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 07-nov-2022.H6: investigation summary: sample and photos received by our quality team for investigation.Upon visual inspection, missing lid is observed on the sample received.A device history review was performed for reported lot 1273459 , no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
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Event Description
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It was reported that the bd descartex¿ ii sharps collector was shipped without a lid.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "1.Lot: 1273459 - item came in the shipping box without the lid.1 unit.".
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Search Alerts/Recalls
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