Unique device identifier (udi): (b)(4).The catheter was not returned for evaluation (per customer; is not available) and no lot number information has been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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2 of 2 reports.Other mfg report number: 3013886523-2020-00192.A facility reported the codman certas valve with sg (model 828804 )and a plain silicon catheter (model refs 823041 and 821684) were implanted to a (b)(6) year old male patient on october 19.Three days post op, the surgeon noticed csf leaking from the incision site.On october 22, the surgeon took the patient back to the or and the certas plus valve and peritoneal catheter were revised (catheter model ref 821684 holter distal peritoneal catheter).It was noted that the valve had split down the middle and the peritoneal catheter had dislodged at the valve connection point.The siphon guard had completely dislodged from the valve.The patient did not experience a fall or hit to the head post op and the surgeon stated that they did not bend the valve on insertion.The ventricular catheter was not revised (model ref 823041 hakim ventricular catheter).
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