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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint that the catheter was not reaching 300 psi was inconclusive as the affected product was not returned for investigation.One unopened picc kit (s1395108d4) from lot #ref (b)(4).Was returned for investigation.The components in the kit exhibited no damage or defect.A functional test of the catheter showed no occlusions or restrictions within the catheter.The dimensions of the power injectable lumen was within specification.While the affected catheter may have partially occluded during use, the unused returned sample showed no damage.For the 5 fr triple-lumen catheter, the information provided in the picc kit indicates an average internal catheter pressure of 153 psi during power injection at 5 ml/sec with injection safety cut-off at 300 psi, using contrast media with 11.8 cp viscosity.Since the affected product was not returned, the exact cause of the reported event could not be determined.H3 other text : evaluation findings are in section h.11.
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