There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information, we are unable to determine where the device was manufactured.Medical device expiration date: unknown.Device manufacture date: unknown.Results: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number for this incident was not provided.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Udi #: unknown.
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On 10/12/2016, bd received the following information via medwatch 5065014: "on (b)(6) 2016, i had an injection into my left eye for the treatment of wet amd.As i left the office, i knew something was different.Immediately after a shot, my vision is often distorted and the eye uncomfortable but now i had lots of material that looked like debris along with opaque, white bubbles with black outlines in my field of vision.This has not cleared.The bubbles are silicone and the debris most likely protein aggregates and degraded stopper particles.My md is suggesting a vitrectomy.Compounded avastin was injected into my left eye with a bd insulin syringe.My eye is now filled with silicon lubricant droplets and other unnamed debris.Very difficult situation visually.Name of company that made (or compounds) the product: (b)(4) makes the avastin.It was compounded by (b)(6).Is the product compounded: yes.Is the product over-the-counter: no.Did the problem stop after the person reduced the dose or stopped taking or using the product: no" a specific bd device was not reported and when bd contacted the customer for additional information she stated that the device may have been a 1ml bd insulin syringe but did not have any further information.As of the date of this report, there has been no reports of the patient receiving any medical or surgical interventions.
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