H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, ecg printout analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a discrepancy between the ecg printout and an incidental x-ray was inconclusive due to the sample condition.An ecg printout from a 5fr t/l powerpicc provena catheter placement was returned for evaluation.The p-wave was present, identifiable, and consistent.The p-wave did appear to peak in the intravascular waveform and does appears to be consistent with a caj placement.Negative deflections were not noted on the 3 complexes on the printout.However, as the printout is a snapshot in time, only the user would be able to tell if they inserted the picc tip deep enough to see the p-wave maximize and then start to diminish or display an initial negative deflection.Without a copy of the radiographic images, a review of the images could not be independently conducted.Possible contributing factors for an ecg printout indicating the incorrect catheter tip location could include patient physiology (e.G., heart rhythm anomalies), the 3cg tcs not properly reading the stylet/ecg (e.G., noise on the signal), or clinical procedure.Possible contributing factors for actual or perceived changes in catheter tip location in the radiographic images could include imaging technique (e.G., projection, patient position, and respiratory pattern), patient movements, or catheter securement method.As the complaint could not be independently confirmed, it will be recorded as inconclusive.However, the complaint has been documented and will continue to be monitored as part of ongoing trending.
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