This is 4 of 4 reports linked to mfg report numbers: 2648988-2021-00018, 2648988-2021-00020, 9612007-2021-00038.A facility reported that lumbar catheter (910121) was observed leaking on arrival to unit, dressing changed with sterile technique was done.Patient had severe headache.First cerebrospinal fluid (csf) culture was clean, then on (b)(6) 2021, neutrophils went from 2 to 77, protein / glucose was fine.Patient on ancef, culture/sensitivity showed no growing organisms.Patient was later discharged on (b)(6) 2021.
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The lumbar cath.Access.Kit (lcak) (910121) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The complaint is considered unverifiable and its exact root cause undetermined.The user did not report any observable product defect prior to the procedure.No information regarding insertion procedure was provided.Per risk file, the most likely cause is procedure-related.Spinal fluid may leak around the catheter and its dressing and the leakage can occur as a result of csf bypassing the insertion site, in which case the dressing will become wet.It can also occur due to placement of the catheter, damage to the drain tubing, catheter dislodgement.Dressings of the evd site need to be routinely checked, observed, and documented by hospital staff to ensure a leak has not occurred.No further investigation or corrective action is deemed required.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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