Catalog Number 170605-000160 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2015 |
Event Type
malfunction
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Event Description
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Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.
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Manufacturer Narrative
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(b)(4).The device history record for lot 14le49 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Visual examination was conducted on the returned catheter and it was observed that the balloon had split.The returned sample was 100% visually inspected using magnification lens.The sample revealed scratch marks along the split area.Catheter with defective balloon will be culled out before being sent to the next process and subjected to a leak test.Catheters with defective balloon will be culled during this process.Based on the investigation conducted, split balloon would likely occur due to balloon being subjected to the sharp object which would cause the split balloon.Therefore, we could not confirm this complaint, as stated.
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Event Description
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Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped.The patient's condition was reported as fine.
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Search Alerts/Recalls
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