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Catalog Number 303172 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that 136 syringe 1ml ls sp120 had the syringe and mating component spin out the following information was provided by the initial reporter: according to the customer's report, due to a large amount of silicone oil, such issues as the connection site becoming slimy and the needle easily coming off are occurring at increased frequency.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-07.H6: investigation summary: samples received for investigation, upon visual inspection of the samples, no excessive silicone is noticed in the fluid path.No other defects can be noticed.A device history review was performed for lot 2009096, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Lubricant is employed during the syringe assembly process to lubricate the cylinders in the silicone station.The silicone employed in this product is a medical grade silicone authorized for product use.Silicone content tests are performed during the manufacturing process of each lot number.Results were reviewed for lot 2009096 and found to be within specification.Testing was performed on the samples, results verified amount of silicone was with the required limits.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
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Event Description
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It was reported that 136 syringe 1ml ls sp120 had the syringe and mating component spin out the following information was provided by the initial reporter: " according to the customer's report, due to a large amount of silicone oil, such issues as the connection site becoming slimy and the needle easily coming off are occurring at increased frequency.".
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Search Alerts/Recalls
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