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Catalog Number H787114030020 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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Event Description
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An end user reported that the account has received 3 broken nevertouch frs 65cm procedure kits.There was no report of patient involvement, by the end user, as the issue was discovered while unpacking the devices.No further details were able to be provided.Device 3 of 3.
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Manufacturer Narrative
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The customer's reported complaint description "the account has received 3 broken nevertouch items" could not be confirmed as no product was returned and no pictures provided.Customer did not provide a clear description of what was broken, however, given that this product is an evlt fiber kit the failure mode in question was assigned to be "fiber found to be fractured in the packaging." without receiving a sample, a definitive root cause cannot be determined.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use (16900393-01) which is supplied to the end user with this catalog number states."do not use if sterile barrier is damaged.If damage is found, call your sales representative.Inspect prior to use to verify that no damage has occurred during shipping." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).
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Manufacturer Narrative
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Returned for evaluation was an unopened companion sample of the same reported lot number.The sample had no signs of damage/defect, to any component of the device; therefore, no additional investigation actions were warranted.Reference (b)(4).
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Search Alerts/Recalls
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