Catalog Number 171305-000140 |
Device Problems
Break (1069); Deflation Problem (1149)
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Patient Problem
No Information (3190)
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Event Date 06/19/2015 |
Event Type
malfunction
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Event Description
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Alleged event: the indwelling catheter was cut at the level of the connection.The balloon was deflated and the catheter was removed.The report description does not clearly define if the catheter was broken or if the device was unable to be deflated and had to be cut for removal.The patient's condition was reported as unknown.
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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 (14le52) was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Actual samples were returned for investigation and it was observed that the sample was intact and without any issues.Further examination on the actual sample using magnifying lens (10x magnification) did not reveal any sign of abrasion mark or scratch to suggest any manufacturing inadequacy.Based on our experience, it is very unlikely that the catheter could have detached without any external force or external contact.The tube was molded using injection molding machine where tube will be physically mounted in liquid silicone before it gets heated and molded inside the funnel.We did not find any problem within the product, which could have contributed from manufacturing processes.The actual returned sample was tested and complied with required standards.Therefore, we could not confirm this complaint.
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Event Description
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Alleged event: the indwelling catheter was cut at the level of the connection.The balloon was deflated and the catheter was removed.The report description does not clearly define if the catheter was broken or if the device was unable to be deflated and had to be cut for removal.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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