An end user reported an issue with a nevertouch 45cm kit.While opening the kit for a procedure, the doctor noted that the laser fiber was kinked.The procedure was completed with another kit.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.
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The reported complaint event description of fiber kinked (out of the package) was assessed as meeting the requirements for mdr reportability, however, the dilator component was returned and confirmed to be kinked.The incorrect reporting was confirmed in a good faith effort to the end user.The complaint event is not deemed to be a reportable event for a kinked dilator.This report is being submitted in order to close out the complaint file.Returned for evaluation was a dilator, there was no fiber assembly returned for evaluation.The returned dilator was noted to have a kink at 39.8cm from hub.The customer's reported complaint description of the dilator tubing was kinked/bent was confirmed upon evaluation of the returned sample.The kink in the dilator tubing is consistent with handling damage to the device, however, when this occurred cannot be definitively determined.A device history records search for the nevertouch kit revealed no quality related issues or manufacturing deficiencies at the time of manufacture.During the manufacturing process, the disposable fiber device receives a 100% inspection and an aql inspection in which the quality of the fiber strip is inspected.Prior to packaging, all components are inspected for damage.The dilator and the tre-sheath are packaged in shipping tubes to prevent damage.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.Reference: (b)(4).
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