[183970568]
To the best of my knowledge, coloplast introduced the speedicath coude flex catheter during the first half of 2017. I began using this catheter in (b)(6) 2017. The original straight-tip speed cath coude flex was an excellent product. I had no problems using this catheter 1,920 times from (b)(6) 2017 through (b)(6) 2018. After a complaint from a competitor that the original straight-tip-speedicath coude flex did not have a curved tip, instead of removing the word coude from the label, coloplast chose to redesign the tip of the original catheter from a straight-tip to design and renamed the catheter speedicath coude flex pro. Since the introduction of the speedicath flex coude pro catheter in early 2019, i have contacted coloplast reps by phone and email several times regarding a design and/or mfg flaw of some bent-tip-speedicath flex coude pro catheters. Although coloplast advertises this new design as a curved-tip catheter, nearly all of them have a sharply-bent tip that renders approx 10% of these catheters: unable to be inserted, have the tip bend in half during insertion, and in some cases cause bleeding. During a phone call with a coloplast rep on (b)(6) 2019, i was informed the original straight-tip coloplast speedicath flex coude catheter is still being manufactured and is currently available to customers in europe. Coloplast will neither confirm nor deny this. When i started using the straight-tip coloplast speedicath flex coude catheter, i was using 120 catheters a month. At that time, the unit price of these catheters was (b)(6) and (b)(6) was paying (b)(6) each month. Some time around (b)(6) 2019 or (b)(6) 2020 i began to use 150 catheters a month. The unit price of the bent-tip coloplast speed cath flex coude pro catheters is (b)(6) and (b)(6) is paying (b)(6) each month. Coloplast's decision to market the inferior bent-tip catheter instead of the excellent straight-tip catheter has resulted in a 64% increase of changes to (b)(6) and profit to coloplast. From early (b)(6) 2019 to (b)(6) 2020 i have saved catalog and lot numbers, dates and time of use, and specific problems of one hundred (100) defective catheters that were unable to be inserted, had the tip bend completely in half during insertion making it painful to withdraw, and/or caused bleeding while being inserted or removed. I contacted (b)(4), marketing director at coloplast corp and (b)(4), senior media relations mgr by email on (b)(6) 2019 and (b)(6) 2020 regarding the design and/or mfg flaw of some bent-tip speedicath flex coude pro catheters. My concerns have been dismissed by coloplast. The design / mfg flaw is now the bent tip of the redesigned speedicath flex coude pro catheters is formed. The tip on nearly all of the redesigned catheters is not curved(coude); it is bent. A small number of the redesigned catheters have a very slight curve, and these catheters are easy to insert. The position of the tip immediately before inserting the catheter is determined by the angle at which the catheter tube is fused to the rubber ends during manufacture. If the tip is angled up and to the left, the catheter cannot be fully inserted or folds completely in half. This results in painful extraction and sometimes causes bleeding. This occurs in approx 10% of the redesigned catheters. The original straight-tip speedicath flex coude catheters did not have this problem. Does the fda consider the 10% failure rate of speedicath flex coude pro catheters at over double the cost to (b)(6) acceptable? Respectfully, (b)(6). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5