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Model Number 8881245164 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 11/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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Submit date: 11/28/2017.An investigation is currently underway.Upon completion, the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The customer reports that the bone marrow aspirate needle broke off in the patient's iliac crest during a procedure.Forceps were used to pull out the broken piece.
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Manufacturer Narrative
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The report refers to product code 8881245164 illinois sternal-illiac needle with lot number 170300024.A device history record was reviewed and was confirmed that products were produced accomplishing quality requirements no non-conformance reports (ncr)s were found it.No samples were provided for evaluation, the preventive and corrective actions for this complaint will be documented on a formal corrective/preventative action (capa).A qa alert was issued at the manufacturing facility for the incoming inspection area.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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