A device history record (dhr) review was performed and no discrepancies that may have contributed to a complaint of this failure mode were found.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.The product sample was received for analysis and investigation; it consisted of two uvc catheters and two syringes which came inside a generic plastic bag and presented signs of use.Visual inspection was performed and it was observed that the catheters did not present any visible defects.In order to confirm the reported condition, a functional test was required and as a result bubbles were detected for both catheters.Visual evaluation of the location of the bubbles was performed; for one of the catheters a kind cut was found closed to the bottom of the strain relief, for the other catheter two holes below the strain relief were identified.Two used samples were received in a package labeled with 3 complaint numbers.All dhrs are reviewed for accuracy prior to product release.In addition, during the manufacturing process, catheters are submitted to a 100% pressure testing.Based on the appearance of the catheters received it is possible that the catheter body was damaged by instruments with sharp or rough edges during clinical use, resulting in a catheter leakage or breakage.It is important to consider that the instructions for use warn to exercise caution when using sharp instruments near the catheter.Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter.Do not pinch or bend the catheter back to temporarily occlude the catheter.This causes increased stress on the catheter which can lead to a leak or break.Do not use alcohol, acetone, or alcohol containing antiseptics directly on the catheter.Carefully check antiseptic solutions for alcohol or acetone.These substances may cause irreversible damage to the polyurethane which can lead to a leak or break.Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter.There are a number of alternatives in the field like exposure to chemical agents, proximity to heat sources or manipulation that may lead to a tubing tear.The defect found caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time; therefore the most probable root cause can be considered that the damage likely occurred during use caused due to inappropriate manipulation.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling according to procedure) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.
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