The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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03/26/2019 - the following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the reported issue of picc malposition is inconclusive as the physical sample was not returned for evaluation.Sales rep indicated there were no further issues with the equipment after additional training was provided to the users, however, details on training provided could not be obtained.It cannot be determined from the chest x-ray whether or not the picc was malpositioned.The ecg strip appears to show some interference in the external ecg waveform, but none in the intravascular waveform.Without a clear, consistent p-wave to use as a reference in the external ecg waveforms, the ifu advises not to rely upon sherlock 3cg tcs placement confirmation to eliminate chest x-ray confirmation.It is possible the interference observed in the external ecg waveform may have led to the picc malposition due to lack of p-wave reference, however, this cannot be determined with the limited information available.The root cause of the event is therefore inconclusive.The device has not been returned to the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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