Catalog Number 302238 |
Device Problems
Break (1069); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2101073.Medical device expiration date: 2025-12-31.Device manufacture date: 2021-01-15.Medical device lot #: 2103099.Medical device expiration date: 2026-02-28.Device manufacture date: 2021-03-24.Medical device lot #: 2102092.Medical device expiration date: 2026-01-31.Device manufacture date: 2021-02-25.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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Event Description
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It was reported when using the syringe 50ml ll convenience tray europe there was a damaged/deformed product - device is operable and foreign matter in the syringe or any fluid path component.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "when opening the 50 ml plastipack convenience pack it is noted that the syringes appear battered and cloudy.".
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Event Description
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It was reported when using the syringe 50ml ll convenience tray europe there was a damaged/deformed product - device is operable and foreign matter in the syringe or any fluid path component.This event occurred 3 times.The following information was provided by the initial reporter.The customer stated: "when opening the 50 ml plastipack convenience pack it is noted that the syringes appear battered and cloudy.".
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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: 2021-09-21.H6: investigation summary one convenience pack reference 302238 and lot number 2101073 received for investigation.Lots 2103099 and 2102092 were also claimed but no samples are available.Upon visual inspection of the syringes, it can be observed the material is transparent and correctly molded.No hits in the barrel can be observed.Damage in the flange, near the bottom of the syringe can be seen.In this part of the syringe there is a circumference around the barrel caused by the marking machine, when the syringe is positioned to stamp the scale.This process, can leave a light mark in the barrel that can be related with the defect described by customer.A device history review was performed and found no non-conformances associated with this issue during the production of lots 2101073, 2103099 and 2102092 all product was manufactured according to specification.Possible root cause is associated with the marking process.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.
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Search Alerts/Recalls
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