Model Number 741 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A sample is anticipated, but not yet received for evaluation.The batch review did not find any nonconformances related to the reported condition during the manufacture of this device.A follow-up report will be submitted once the evaluation results become available.
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Event Description
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It was reported that the fill port of the tpn therapy bag was found to be mangled or crushed after being removed from the outer wrap.This report documents no patient involvement or adverse events.No additional information is available.
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Manufacturer Narrative
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(b)(4).Evaluation summary: the reported sample was returned for evaluation.The visual inspection identified the reported issue and confirmed that there was a significant damage to the end of the fill port tubing and the fill port was not installed.This damage to the fill port tubing was determined to have been caused by the tubing being misaligned in the manufacturing equipment during fill port installation.Manufacturing controls are in place to reduce the likelihood of recurrence of this defect including startup and 100% final visual inspection, as well as in process inspection.Should additional relevant information become available, a follow-up report will be submitted.
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Search Alerts/Recalls
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