H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one quick connect hub was received for evaluation.Upon visual evaluation and microscopic visual observation, the device appeared to have black residue in the inner side of the connect hub.There were no visual anomalies noted on the device.And it was noted that the proximal u-clip was not visible within the quick connect hub.Therefore, the investigation is confirmed for the reported unintended movement issue as the device was received with u-clips not visible.And the investigation is confirmed for the identified device contamination with chemical or other material issue as the black residue was noted in the inner side of the connect hub.A definitive root cause for the reported unintended movement issue was due to the u-clip was not visible.Then, definitive root cause for the identified device contamination with chemical or other material issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provided 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.
|
It was reported that during a femur biopsy procedure, the quick connect hub had allegedly started to wobble and lost the rpm's about fifteen seconds into drilling.It was further reported that another two sleeves were opened, and both had the same issue after about the same amount of drilling.The procedure was completed by using another device.There was no reported patient injury.
|