Catalog Number 325108 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/28/2019 |
Event Type
Injury
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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 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 pn 31x8 france 100bx needle broke off inside the patient and remained in the arm.This was discovered during use.The following information was provided by the initial reporter: please register a new material vigilance declaration made this morning by the pharmacy.A customer reported to her by phone that she had had a pb with a needle.The needle broke cleanly at the base and remained implanted in the arm of the patient, his son.
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Manufacturer Narrative
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Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.
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Event Description
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It was reported that pn 31x8 france 100bx needle broke off inside the patient and remained in the arm.This was discovered during use.The following information was provided by the initial reporter: please register a new material vigilance declaration made this morning by the pharmacy.A customer reported to her by phone that she had had a pb with a needle.The needle broke cleanly at the base and remained implanted in the arm of the patient, his son.
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Search Alerts/Recalls
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