No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.As a result of observing the sample, it was confirmed that the hinge part of the connector was damaged.The root cause of the reported issue was found to be hinges were most likely cracked during transportation after shipping.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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It was reported that after indwelling the catheter in the patient during the medical procedure of epidural anesthesia, the customer connected the catheter to the connector and conducted a test dose of medical fluid.After that, when he opened the connector, he noticed its hinge part broke.No patient injury was reported.
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