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Model Number 26547 |
Device Problem
Material Separation (1562)
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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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The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported, the luer tip of the device was detached inside the package.
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Manufacturer Narrative
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The device history record (dhr) for the reported lot indicates no issues were found in visual and physical samples inspected.There were no nonconformance reports (ncr) related to this lot.There were no samples submitted with this complaint, however, a picture was sent by the customer and was analyzed.The needle hub looked to be fractured into 2 pieces.The reported condition is confirmed based on the customer provided image.The exact root cause of the reported condition could not be determined without a physical sample to examine.There was no indication of a systemic issue with the process or production.Based on available information, no corrective actions are required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.
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Search Alerts/Recalls
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