The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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A device history review (dhr) revealed no discrepancies that may have contributed to the reported issue.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.In addition, all dhr are reviewed for accuracy prior to product release.One photo was provided by the customer for analysis and investigation.According to the visual inspection of the photo, the catheter was used as blood was observed on the catheter.Blood was also observed coming out near the ¿y¿ junction.The reported issue of leaking was confirmed.Based on all available information, it can be concluded that the product was manufactured according to specifications.Therefore the most probable root cause is that the leak was caused by damage while in use.It¿s important to consider that the instructions for use state: do not use sharp clamp or instrument to handle the catheter since even a minor cut could tear or break the catheter.Do not stretch catheter, too much tension could tear the catheter.Do not use alcohol or acetone-based skin preparations, adhesive enhancers, or solutions directly on the catheter.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) 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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