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 bard magnum biopsy needle was returned for evaluation.On visual evaluation, the device appeared to have blood residue throughout and the device was received with sample notch exposed condition.And it was noted that the stylet needle was not seated correctly on the hub.Due to the condition of the device and the nature of the complaint, functional testing was not performed.On dimensional observations, the cannula length was not found to be in the acceptable range.Therefore, the investigation for the identified non-standard device is confirmed as the cannula length was not in the acceptable range.However, the investigation for the reported device markings and labelling problem is kept as inconclusive as the identified issue may contributed to the reported issue.Therefore, the investigation for the reported failure to obtain sample is kept as inconclusive as the functional testing was not performed.One electronic photo was provided for review.Photo shows two blocks where the first block shows two magnum needle which were focused on the hubs (one is defective device and other is normal device).Second block shows the needle portion (i.E stylet) of the needles where the length of the stylet for the defective needle is longer than the normal needle which is kept along the needle.Therefore, based on the photo review, the reported failure failure to obtain sample and device markings/labelling problem could not be confirmed.However, based on the photo review, the identified non-standard device can be confirmed.Therefore ,the investigation for the reported failure to obtain samples and device markings/labelling problem is kept as inconclusive as there were no proper evident provided.However, the investigation for the identified non-standard device can be confirmed.A definitive root cause for the alleged failure to obtain samples and device markings/labelling problem and the identified non-standard device could not be determined based upon the provided information.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 (expiration date: 06/2024), g3, h6 (device, 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.
|