Catalog Number 4252543-020 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
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Event Description
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As reported by the user facility: it was reported that foreign matter was seen on the product.No injury reported.
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Manufacturer Narrative
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His report has been identified as b.Braun medical internal report number (b)(4).No sample was retruned for further evaluation.However, a picture of the blister lid confirming the reported lot number was provided.Visual examination of the photo was unable to confirm any defects.The reported defect was not confirmed.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
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Search Alerts/Recalls
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