[113038869]
We have started to report this adverse event since 5. 25. However, due to some possible technical problems, we have not successfully submitted the documents. Therefore, we consulted with fda officials and maintained close communication to solve the problem. Fda officials have suggested that we can address the reasons for not being able to report in a timely manner in this section.
Patient Sequence No: 1, Text Type: N, H10
[113038890]
On (b)(6) 2018, our us client alere randomly selected our product one step multi-drug oral fluid test cube (lot no. W61080201,w61080202,w60680202) for inspection. Fifteen saliva sponge collectors (accessories of the test cube) were selected and it was found that 5 of the 15 foam tips had fallen off. This product meet the internal specifications, is used for diagnosis and the failure of the accessory may lead to a mdr reportable events. The potential failure of the sponge collector may lead to the following consequences: (1) affecting the use of the product; (2) causing risks of eating because the foam tip may be dislodged in the user's mouth. We have conducted an investigation and the causes of the failure are identified as follows: (1) for structural design: the outer surface of the foam tip is not fixed, and it is only affixed by hot-melt adhesive on the end face, which makes it easy to fall off. (2) for process flow: a) according to the existing product technology, hot-melt adhesives must be spotted to the plastic parts first, and then the sponges will be assembled. The process cannot be controlled due to manual operations, which may cause the hotmelt adhesives to cure in advance and the adhesion is not good. B) no key parameters for this process, only relying on the visual inspection and control of employees, and the lack of standards for the amount of glue leads to uneven coating. (3) quality control: no controlled sop for this process. There is only one internal operation guideline, which cannot ensure the operators perform according to the guidelines. Quality supervision is missing. Corrective or removal actions: (1) ask our client to return the products to wondfo, and the products will be put in the designated area and isolated. The involved batches that the accessory failure may exist in are: w61071201, w61071202, w60680201, w60680202, w60880201, w61080201, w61080202, w60980201, w61080402, w60680401 (estimated completion time: 2018-6-15). (2) reassess the rationality of the existing production processes and the effectiveness of the existing quality control (estimated completion time: 2018-6-30). (3) revise the relevant sop and retrain the relevant personnel. Only the personnel who pass the exam can take up posts (estimated completion time: 2018-6-30). (4) replace the products for the customers (estimated completion time: within one month after the products are returned). To date, there have been no reported instances of death or injury associated with this product failure.
Patient Sequence No: 1, Text Type: D, B5