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 lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter obstruction is confirmed.One 4 fr groshong was returned for evaluation.The one-piece connector was assembled with the catheter.Blood residue and solidified, light-brown residue was visible within the catheter tubing.The catheter was flushed with water and was found to be partially occluded.Microscopic observation of valve slit location revealed the light-brown residue to be present within the tubing and between the valve slit.The residue was found to be affecting the functionality and sealing of the valve and likely resulted in the occlusion of the catheter.The valve slit length was measured and was found to be within manufacturing specification.A review of the manufacturing records did not reveal evidence to suggest a manufacturing related root cause contributed to the reported event.The product instructions for use (ifu) contains information in the "suggested catheter maintenance" section which may have prevented the reported issue.A lot history review (lhr) of redn0218 showed no other similar product complaint(s) from this lot number.
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