H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and incidental stretching was noted to the device in the sheath.No other anomalies were noted to the device.The device was removed from the sheath and the device was not be received in two segments.Therefore, the investigation is confirmed for the reported retraction issue, as the device was returned stuck in a sheath with stretching noted to the device.The investigation is also confirmed for the detachment, as the device was received in two segments.The definitive root cause for the retraction issue and detachment could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 03/2023).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.
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