Model Number 1012268-12U |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/05/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
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Event Description
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It was reported that prior to being given to a hospital, the distributor noted that a 1.2x12mm mini trek balloon dilatation catheter (bdc) had a hole in the packaging pouch, which likely led to compromised sterility.The device was not used and there was no patient involvement.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10: the device is no longer returning.
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Search Alerts/Recalls
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