Catalog Number 305136 |
Device Problem
Break (1069)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2024 |
Event Type
Injury
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Event Description
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Materials#: 305136.Batch#: 2021694.It was reported by the customer that needle snapping off at hub.Verbatim: rcc received a complaint via email.Customer reports needle snapping off at hub.This has happened before, however on (b)(6) 2024, states giving injection to patient and needle snapped off in patient buttock and sent to hospital.Product#: 305136.Lot#: 2021694.
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Manufacturer Narrative
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(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Manufacturer Narrative
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(b)(4) follow up, a device history record review was completed by our quality engineer team for provided material number 305136 and lot number 2021694.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
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Event Description
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No additional information received.Materials#: 305136, batch#: 2021694.It was reported by the customer that needle snapping off at hub.Verbatim: rcc received a complaint via email.Email(s) attached.Customer reports needle snapping off at hub this has happened before however on (b)(6) 2024 states giving injection to patient and needle snapped off in patient buttock and sent to hospital.Product#: 305136.Lot#: 2021694.
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Search Alerts/Recalls
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