Model Number 405671 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2023 |
Event Type
malfunction
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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.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
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Event Description
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It was reported that 3 inner wrapping of the bd¿ whitacre spinal tray were discovered to have holes.The following information was provided by the initial reporter: mat# 405671.It was reported by the customer "incident at (b)(6) hospital involving bd spinal trays lot # 405671.3 kits were discovered to have holes in the inner wrapping." verbatim: 3 kits were discovered to have holes in the inner wrapping.
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Manufacturer Narrative
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H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.
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Event Description
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It was reported that 3 inner wrapping of the bd¿ whitacre spinal tray were discovered to have holes.The following information was provided by the initial reporter: mat# 405671.It was reported by the customer "incident at ccf medina hospital involving bd spinal trays lot # 405671.3 kits were discovered to have holes in the inner wrapping." verbatim: 3 kits were discovered to have holes in the inner wrapping.
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Search Alerts/Recalls
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