As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiration date: 05/2025.
|
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot; however, a manufacturing review was performed to verify manufacturing records as the user reported foreign material in the packaging.The lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported device contamination issue could not be determined based upon the provided information.Labeling review: the instructions for use included in this product prescribes the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.Instruction for use precautions: 1.Sterile, unless the package is opened or damaged.Single use only.2.These products are sterilized by ethylene oxide.Do not resterilize.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: b5, d4 (expiration date: 05/2025), g3, h6 (method).H11:section a through f - the information provided by bd represents all of 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.
|