Date of event: unknown.The date received by manufacturer has been used for this field.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.
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H.6.Investigation: to aid in the investigation of this issue, a video sample was provided for evaluation by our quality engineer team.Through examination of the video, it can be observed that the plunger rod bends easily and that there was plunger movement difficulty.The characteristic of the soloshot mini syringes is that the plunger cannot be depressed once the clip has been activated.It has been determined that the issues of plunger rod bends and plunger movement difficulty resulted from the handling of the product.The bd soloshot mini auto-disable syringes are single-use medical devices.The auto-disable syringe consists of two plastic parts called the plunger and the cylinder and a metallic piece called the clip.The function of this clip is to avoid reuse of the syringe to prevent infection transmission.Once the clip is activated, the plunger cannot be depressed and the plunger will appear stuck if pushed.The user should ensure that the syringe is totally closed before drawing up the medication.Picture samples were returned for evaluation of foreign matter on the product.Through examination of the pictures, our quality engineer team identified two different types of black foreign matter within the blister packages.It is possible that the pictured foreign matter originated from some residue within the packaging machinery used.Regrettably, without the physical sample, further analysis cannot be performed to identify the composition and exact origin of the foreign matter pictured.As a lot number was unknown for this incident, a device history record review could not be completed.H3 other text : see h.10.
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