Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is hdq (b)(4).This site is an (b)(4)manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
|
The following fields were updated due to additional information: d.4.Medical device lot #: 8324931 d.4.Medical device expiration date: na h.4.Device manufacture date: 11/19/2018 h.6.Investigation: according to the dhr review process; the result showed there were no issues reported like trolley damaged during the manufacturing process of the lot number reported under this customer complaint.A review of the ncmr¿s was performed; the result showed there were no issues reported like trolley damaged for the same part number throughout the last twelve months.Ccording with this investigation and the information provided from the customer (photos) it could be seen a nut damaged, a lot number (8324931) manufactured in 2018 and a box from flex (relabeled).For this reason, it can be concluded that there are many variables that could generate this failure mode as incorrect handling, not controlled repackaging process, not suitable packing, transportation damages, etc.Therefore, additional information (handling method used by the distributor, photos of transportation) is needed to determine the possible root cause that leads to this issue.
|