(b)(4).Additional information: the actual device batch number associated with this event is not known.Three possible batch numbers are reported as follows: batch llz901 expiration date: 09/30/2022.Date of mfg.: 10/18/2017; batch mb6471 expiration date: 01/31/2023 date of mfg.: 02/19/2018; batch lm6405 expiration date: 10/31/2022 date of mfg.: 11/17/2017.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested, but unavailable: lot #? when was it noticed the needles were detaching (pre-op/ before use on patient? or intra-op /during use on patient while suturing?) it is reported "this issue has occurred in an unknown number of procedures" can you provide the total number of procedures? was this reported previously? if yes, provide complaint reference numbers? for each procedure provide the following: event description; product code and lot number; event date; procedure name; patient consequences/ae report if any? qty involved? sample return, if any? were the procedures completed successfully? and how?.
|