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Model Number 714170 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2022 |
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 that the tube was inserted on (b)(6) 2022 and the balloon burst on (b)(6) 2022.There was no harm reported.Additional information was received and stated that the hole causing balloon to deflate and size of hole not specified.It was a clean tear.There was a no patient harm reported.
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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 device was manufactured on (b)(6) 2021.A sample have not yet been received at the manufacturing site for investigation.Because a sample was not returned, we were unable to perform a follow-up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Since the device is provided by an external supplier, a corrective action (capa) has been generated to the supplier to determine the root cause and corrective and preventive actions, if required.This complaint will be used for tracing and trending purposes.
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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 device was manufactured on 10-jun-2021.The sample was visually and functionally inspected, and the reported condition was confirmed.The affected component is produced by an external supplier.A supplier corrective action request (scar) has been issued to the supplier for further investigation and to address the reported condition.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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