Catalog Number 309632 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D.4.Other lot number includes 3101292 and other expiration date includes 03/31/2028.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.H.4.Other lot number device manufacture date is 04/11/2023.
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Event Description
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It was reported, that the bd luer-lok syringe had leakage.The following information was provided by the initial reporter: "it's hard to see but when the provider injects medication it comes out the side of the syringe.Speculating a hairline crack somewhere on the device.".
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Event Description
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No additional information.
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Manufacturer Narrative
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(b)(4) - follow up mdr for device evaluation.It was reported medication it comes out the side of the syringe.To aid in the investigation, one hundred seventy-three samples of 5m luer lok syringes from lots 3101292 and 3174004 were received for evaluation by our quality team.Ninety samples were from lot 3174004 and eighty-three samples were from lot 3101292.Each sample was visually inspected, and pressure tested for leakage.No samples were found to have any cracks or leakage.The samples returned are acceptable per product specification.A device history record review was completed for provided material number 309632, lots 3101292 and 3174004.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Lots 3101292 and 3174004 were inspected and accepted based on meeting our inspection control plan, subsequently approved for shipment and are considered in compliance with our product specification requirements.No corrective action is required at this time.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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Search Alerts/Recalls
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