Catalog Number 301948 |
Device Problem
Fungus in Device Environment (2316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that 80 bd¿ 20 ml syringes with needle had mold presence.The following information was provided by the initial reporter: "when we opened the package, it found that there were mildew spots in one box".
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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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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 80 bd¿ 20 ml syringes with needle had mold presence.The following information was provided by the initial reporter: "when we opened the package, it found that there were mildew spots in one box".
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Event Description
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It was reported that 80 bd¿ 20 ml syringes with needle had mold presence.The following information was provided by the initial reporter: "when we opened the package, it found that there were mildew spots in one box.".
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Manufacturer Narrative
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H.6.Investigation: a device history record review was completed for provided material number 301948 and lot number 2105131.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.As samples were unavailable for return, retained samples were obtained for further evaluation by our quality engineer team.Through examination of the retained samples, no signs of defect could be observed.Based on the limited investigation results, an exact cause could not be determined for the reported incident.
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Search Alerts/Recalls
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