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, 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: product was not returned for evaluation/repair.Photo samples of the ecg tracings and chest x-rays were provided.Radiologist review of the chest x-rays confirmed the initial picc placement was longer than the expected position and tip could be in the right atrium.Furthermore, review of the second chest x-ray confirmed picc was retracted 2 cm and was located at an acceptable location.Radiologist review also noted the difference between the first and second chest x-ray could be related to inspiratory (initial x-ray) versus expiratory (second x-ray) state of the patient, possibly causing the picc placement to appear deep when in actuality it may have been on the upper cusp of normal placement.Complaint investigation and root cause determination could not be completed without physical evaluation of the unit.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.
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