Model Number 8884715148E |
Device Problems
Break (1069); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Event Description
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The customer reported the product broke below the connection site.There was no patient inquiry.Per additional information provided on may 31, 2023, a portion of the y-port broke off/fully detached.The tube was replaced to resolve the issue.
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Manufacturer Narrative
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The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 12-feb-2023.A picture of the catalog was provided for analysis.Based on the information available to us, we were unable to confirm the reported issue.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
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Manufacturer Narrative
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Section b5 has been updated to include additional information received from the customer.Section h6 (medical device problem code) has been updated to include 1250- fluid leak, based on the additional information received.Aware date: originally reported as (b)(6) 2023 and should be (b)(6) 2023.
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Event Description
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The customer reported the product broke below the connection site.There was no patient injury.Per additional information provided by the customer on (b)(6), 2023, a portion of the y-port broke off/fully detached.The tube was replaced to resolve the issue.Per additional information received from the customer on (b)(6) 2023, the piece was completely detached and was moving freely in/out, leaking.The staff was unable to unscrew the formula tubing from the port.
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Search Alerts/Recalls
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