Note: although this report is related to a product that is labeled for use in the veterinary market, the product is identical to product that is labeled for human use.Therefore, this report is being submitted as a precautionary measure.This report was not associated with a human patient.The actual device was not returned to the manufacturing facility for evaluation and the product code and lot number are unknown.Therefore, the investigation was based upon evaluation of user facility information and retention samples from the following random part/lot: sr-ox2225ca / rh2826 as well as the surrounding lots.A visual evaluation under microscope revealed no defects.The production lot number was not provided by the user facility, which prevented a meaningful review of production or complaint records.There is no evidence that this event was related to a device defect or malfunction and the exact cause cannot be determined based on the available information from the user facility and investigation results.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.
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The user facility reported experiencing issues with non-healing wound on an animal patient after using a terumo sr product.The doctor reported he had a (b)(6) animal patient infected with the parvo virus, who has been hospitalized since (b)(6) 2015 free of charge; the animal patient was initially treated with 2 antibiotics and the wound looks much better now.Follow up communication with the user facility reported: the animal patient was presented at the facility with parvo virus; the doctor reported he does not remember who placed the catheter or what size the catheter was; it was reported they typically use 22g or 20g, sometimes 24g; the doctor reported he believed the puppy may have chewed the catheter (ate, came loose, or broke), and extravasation was noted at the time; the doctor reported he was not overly concerned, as edema is common; the doctor placed another catheter in the other forearm without issue; the animal patient went home and returned to the facility a few days later with a decubitus ulcer on (b)(6) 2015; the wound was the size of a quarter and squirted pockets of clear fluid across the room (area had thickened skin, dorsal & proximal to catheter placement); the animal patient is doing much better and the wound has healed, but not completely, without any signs of infection; it was reported the doctor was going to take ap & lateral x-rays on the animal patient's forelimb.Additional information was reported on 1/15/16: the doctor reported he did not observe any catheter pieces or fragments.The reported complaint is the same complaint reported in mdr no.3003902955-2016-00002.Due to the unknown product code and lot number it could not be determined which factory manufactured the unknown surflo.An investigation is being completed on behalf of both tmc and tpc.
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