Model Number BL5277 |
Device Problem
Break (1069)
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Patient Problem
Suture Abrasion (2497)
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Event Date 09/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device has been requested but has not yet been returned.The investigation is ongoing.
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Event Description
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The user facility reported the tip of the needle broke off in the patients eye during use.The incision was enlarged and sutures were required.Additional information has been requested.
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Manufacturer Narrative
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One 23ga needle tip was returned.The original packaging was not returned therefore the part and lot number cannot be determined.Visual inspection found the tip of the needle broken off.Additionally, there is heavy marring, scratches and material missing from around the shaft of the needle above the location of the break.The corners on the hub of the needle are also damaged with rounded corners and marring.The investigation is ongoing.
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Manufacturer Narrative
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The root cause of the reported event could not be determined due to the condition in which the sample was returned and the uncertainty about how it was used or how many times it may have been used.The vendor investigation concluded the defect did not appear to be due to their manufacturing process.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
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Search Alerts/Recalls
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