As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.
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H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for a material separation in the catheter as a separation was noted in the extension leg of the catheter just distal to the catheter hub and also a small proximal catheter segment appears to be attached to the hub in the provided photo.Based upon the available information a definitive root cause could not be determined.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 09/2023), g3, h6(method).H11: d4(medical device lot number), h6 (device, result, conclusion).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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