Model Number 714250 |
Device Problem
Unintended Deflation (4061)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/06/2023 |
Event Type
malfunction
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Event Description
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The customer reported the tube was inserted on (b)(6) 2023 and a hole in the balloon was discovered on (b)(6) 2023.
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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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Manufacturer Narrative
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H4 device manufacture date was added the device history record (dhr) review showed that manufacturing and inspection of product was performed as per applicable procedures and validated process.A sample analysis could not be performed because no samples were available for evaluation.The reported condition could not be confirmed.The affected component is produced by an external supplier.Due to similar cases presented in the past, a corrective and preventative action (capa) has been opened to further investigate this issue.This complaint will be used for tracking and trending purposes.
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Manufacturer Narrative
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The customer returned the device for evaluation.Upon receipt, it was noticed that the returned device does not match the reported device.Upon confirmation from the cardinal health sales rep, section d1 and d4 were updated accordingly.D9 and h3 were updated to reflect that a sample was returned and the evaluation is anticipated.The updated investigation results will be shared when available.
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Manufacturer Narrative
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The device history record (dhr) review showed manufacturing and inspection of product was performed as per applicable procedures and validated processes.One sample was received for evaluation.A visual inspection and a functional test were performed.A pin hole leak was observed in the balloon.The reported condition was confirmed.The affected component is produced by an external supplier.Due to similar cases presented in the past, a formal investigation was opened to further investigate the issue.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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