Catalog Number UNKNOWN |
Device Problems
Detachment Of Device Component (1104); Entrapment of Device (1212)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review was not conducted because a lot number could not be determined.Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.
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Event Description
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It was reported that the needle of an unknown bd¿ insulin syringe/needle detached and remained in the patients skin.There was no report of medical intervention.
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Manufacturer Narrative
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Additional information, the original mdr used the bd awareness date (b)(6) 2017 as the date of event, since it was unknown.The date of event is now known.Date of event: (b)(6) 2017.
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Search Alerts/Recalls
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