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Catalog Number 89-6263 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary an internal complaint ((b)(4)) was received indicating that blue towel contained within an ophthalmology pack ((b)(4)) was linting, causing the surgical staff to reinspect hands after touching the towel.The raw material is supplied to deroyal by (b)(4).A supplier corrective action request (scar) was issued june 22, 2016, to (b)(4) and is due august 4, 2016.A response has not been received at this time.The investigation is ongoing at this time.If new and critical information is received, this report will be updated.
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Event Description
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Lint on the blue towels is coming off on the surgical staff's hands, which is an issue when dealing with the eyes.It causes the staff to have to reinspect their hands to check for lint before returning to the procedure.The incident occurred during use in an ophthalmic procedure.
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Manufacturer Narrative
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Root cause: the towel in the finished good kit is supplied to deroyal by us (b)(4).As such, a supplier corrective action request (scar) was submitted to us (b)(4).In its response, the supplier indicated that the failure could not be confirmed.Representative samples were submitted to a third-party laboratory for evaluation.Results of the evaluation failed to detect lint on the samples submitted.Corrective action: in its scar responds, us (b)(4) stated a corrective action has not been taken.Testing of the representative samples failed to duplicate the reported issue.Investigation summary an internal complaint (call (b)(4)) was received indicating that blue towel contained within an ophthalmology pack (finished good (b)(4), lot number 41735601) was linting, causing the surgical staff to reinspect hands after touching the towel.As part of the us (b)(4) investigation, representative samples were submitted for a third-party lab evaluation.Three lots were inspected, and no traces of lint were present.Additionally, no visible lint was present on retention samples during the folding and delinting process verification.The work order for the finished good was reviewed for discrepancies that would have contributed to the reported event.None were identified.The blue or towel contained within the finished good is raw material (b)(4), which is supplied to deroyal by (b)(4).A two-year review of the scar and supplier notification letter (snl) logs confirmed that similar complaints have been reported for this issue.Preventive action: a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.
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Event Description
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Lint on the blue towels is coming off on the surgical staff's hands, which is an issue when dealing with the eyes.It causes the staff to have to reinspect their hands to check for lint before returning to the procedure.The incident occurred during use in an ophthalmic procedure.
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Search Alerts/Recalls
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