Catalog Number 309633 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Numbness (2415)
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Event Date 08/10/2023 |
Event Type
Injury
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Event Description
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It was reported 5 ml bd luer-lok¿ syringe with attached needle was leaking.The following was received by the initial reporter: reported issue: leaking; (b)(6) 2023.On (b)(6) 2023 one of our medical assistants was drawing up lidocaine using the 5ml (b-d309577 syringe, 21g x 1.5", needle combo) when instead of drawing into the syringe some of the lidocaine came squirting out the side of the needle where the needle attaches to the syringe (green part).The needle was securely attached to the syringe.The lidocaine went into her eye requiring it to be flushed out.She had irritation and numbness to her eye and surrounding tissue for several hours after the incident.I promptly reported the incident to medline to bring awareness to a possible product defect.
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Manufacturer Narrative
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H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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Pr 8990096 - follow up mdr for device evaluation.It was reported there was a leakage issue.As a sample was not returned, a thorough sample evaluation could not be performed.A physical sample is required for a more thorough evaluation and potential root cause determination.A device history record review was completed for provided material number 309633, lot 3060178.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lot 3060178 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Since no samples displaying the reported condition were received corrective actions are not necessary.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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No additional information.
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Search Alerts/Recalls
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