H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one quick connect hub was received for evaluation.Upon visual evaluation, the device appeared to have black residue on the inner side of the quick connect hub.It was noted the proximal u-clips were not visible.Functional testing was not performed, due to the as received sample condition (uclips not visible and noted out of place, unable to connect to power driver).Therefore, the investigation is inconclusive for the reported unintended movement issue as the further functional testing was not performed (u-clips not visible and noted out of place, unable to connect to power driver).The investigation is confirmed for the identified premature separation issue as the device was received with u-clips out of position.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 identified premature separation issue was due to the u-clips not visible and noted out of place.Then, definitive root cause for the remaining reported unintended movement and identified device contamination with chemical or other material issues could not be determined based upon the provided information.It is unknown whether procedural issues contributed to the reported event.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2024) 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.
|