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Catalog Number 515105 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Information (3190)
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Event Date 04/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 that an unknown number of protector p50 experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 515105, batch no: 1812102.Event description states, my technicians are telling me they are having a real hard time with coring.They have tried both types of vial adaptors, but have experienced it with both.The solution is very difficult to filter as it is very thick.Follow up information states: i find we get coring after multiple punctures because you end up puncturing the vial 3 times if not more just to get you required volume, if it¿s our supply we have multiple punctures to the vial because there is overfill so we make sure to get everything out of the vial but if its patient¿s own and will be wasted anyways there aren¿t multiple punctures but regardless there is coring in at least 1 out of the 5 vials being used if not more.
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Event Description
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It was reported that an unknown number of protector p50 experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 515105 batch no: 1812102.Event description states, my technicians are telling me they are having a real hard time with coring.They have tried both types of vial adaptors, but have experienced it with both.The solution is very difficult to filter as it is very thick.Follow up information states, i find we get coring after multiple punctures because you end up puncturing the vial 3 times if not more just to get you required volume, if it¿s our supply we have multiple punctures to the vial because there is overfill so we make sure to get everything out of the vial but if its patient¿s own and will be wasted anyways there aren¿t multiple punctures but regardless there is coring in at least 1 out of the 5 vials being used if not more.
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Manufacturer Narrative
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Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1812102 and no non-conformances were identified during the manufacturing of this batch related to the reported issue.Fragmentation testing was reviewed for the reported lot, results found to be acceptable.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Based on the available information we are not able to identify a definitive root cause at this time.
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Search Alerts/Recalls
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